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Minimally Invasive Structural CVD Repairs: FDA grants 510(k) Clearance to Philips’ EchoNavigator – X-ray and 3-D Ultrasound Image Fused.

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, CABG, Cardiac & Vascular Repair Tools Subsegment, FDA Regulatory Affairs, FDA, CE Mark & Global Regulatory Affairs: process management and strategic planning - GCP, GLP, ISO 14155, Frontiers in Cardiology and Cardiovascular Disorders, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Medical Imaging Technology, Image Processing/Computing, MRI, CT, Nuclear Medicine, Ultra Sound, Mitral Valve: Repair and Replacement, PCI, Valves & Tools, tagged EchoNavigator, Food and Drug Administration, Philips, Philips Healthcare, University Hospital Zurich, University of Colorado Hospital on March 21, 2013| 3 Comments »

Minimally Invasive Structural CVD Repairs: FDA grants 510(k) Clearance to Philips’ EchoNavigator – X-ray and 3-D Ultrasound Image Fused.

Curator: Aviva Lev-Ari, PhD, RN

 

UPDATED on 7/15/2018

The growing role of echocardiography in interventional cardiology: The present and the future

Author links open overlay panelA.P.PatrianakosA.A.ZacharakiE.I.SkalidisM.I.HamilosF.I.ParthenakisP.E.Vardas

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https://doi.org/10.1016/j.hjc.2017.01.008Get rights and content

Open Access funded by Hellenic Cardiological Society

Under a Creative Commons license

Abstract

As structural heart disease interventions continue to evolve to a sophisticated level, accurate and reliable imaging is required for pre-procedural selection of cases, intra-procedural guidance, post-procedural evaluation, and long-term follow-up of patients.

Traditionally, cardiovascular procedures in the catheterization laboratory are guided by fluoroscopy and angiography. Advances in echocardiography can overcome most limitations of conventional imaging modalities and provide successful completion of each step of any catheter–based treatment. Echocardiography’s unique characteristics rendered it the ideal technique for percutaneous catheter-based procedures.

The purpose of this review is to demonstrate the use of the most common and up-to-date echocardiographic techniques in recent non-coronary percutaneous interventional procedures, underlining its inevitable and growing role, as well as illustrating areas of weakness and limitations, and to provide future perspectives.

SOURCE

https://www.sciencedirect.com/science/article/pii/S1109966617300258

 

On January 28, we reported on several FDA Pending 510(k) for The Latest Cardiovascular Imaging Technology

http://pharmaceuticalintelligence.com/2013/01/28/fda-pending-510k-for-the-latest-cardiovascular-imaging-technology/

On March 7, 2013 a very significant, pending clearance event, in favor of Philips Healthcare, was announced:

U.S. FDA Clears Philips’ EchoNavigator for Fused TEE-Angiography Image Guidance

March 7, 2013

March 7, 2013 — Philips Healthcare announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its EchoNavigator live image-guidance tool. The technology helps interventional cardiologists and cardiac surgeons perform minimally invasive structural heart disease repairs by providing an intelligently integrated view of live X-ray and 3-D ultrasound images.

Following the CE marking of EchoNavigator in Europe, Philips will now be able to introduce the system globally, with systems already installed in Europe and the United States.

EchoNavigator was developed in response to an upward trend in the use of both X-ray imaging and 3-D cardiac ultrasound imaging (echocardiography) during structural heart disease procedures — an area of interventional cardiology that is growing at around 40 percent per year. During such procedures, ultrasound imaging provides critical insights into the heart’s soft tissue anatomy, while X-ray imaging has particular strengths in visualizing the catheters and heart implants. EchoNavigator was designed to address the unique challenges associated with working with live X-ray and 3-D ultrasound images simultaneously.

“Together with Philips, we set out to bring two separate medical imaging techniques together in a way that provides clear visual guidance,” said John Carroll, M.D., interventional cardiologist, University of Colorado Hospital, Denver. “EchoNavigator is enabling us to use X-ray images combined with real-time 3-D ultrasound images to navigate catheters and deploy implants in the right position in the heart, making such treatments more straightforward.”

EchoNavigator will enable clinicians to perform procedures more efficiently by providing intelligently integrated X-ray and 3-D ultrasound images into one intuitive and interactive view, as well as providing easy-to-use system navigation and better communication between the multidisciplinary team carrying out the procedure.

“We have learned that ideally two live imaging technologies are needed to guide catheter-based repairs to the heart, and a multidisciplinary team is needed to perform it,” said Roberto Corti, M.D., interventional cardiologist, University Hospital Zurich, Switzerland. “This adds to the complexity of such procedures. The development of a more sophisticated imaging technology such as EchoNavigator will definitely provide us with a better understanding of the complex structures of the heart and their repair.”

“As the global market leader in interventional cardiology, we have worked with our partners to lead the way with pioneering solutions such as our real-time 3-D ultrasound technology and more recently our HeartNavigator navigation tool,” said Gene Saragnese, CEO for Imaging Systems at Philips Healthcare. “EchoNavigator is further evidence of our commitment to transforming healthcare through the introduction of innovations that enable best in class minimally invasive procedures.”

“In the emerging field of complex structural heart disease interventions, the information obtained by merging imaging technologies, as now possible with HeartNavigator and EchoNavigator, will be of tremendous value to the interventionalist, and in turn to the patient,” said Carlos Ruiz, M.D., director of the structural and congenital heart disease program, department of interventional cardiology, Lenox Hill Hospital, New York.

For more information: http://www.healthcare.philips.com

SOURCE:

http://www.dicardiology.com/article/us-fda-clears-philips’-echonavigator-fused-tee-angiography-image-guidance?goback=%2Egde_3693995_member_223204362

 With certainty we ascertain that:

3-D, 4-D Enhancements May Be the Future of Ultrasound

Written By:

Dave Fornell

May 15, 2012

A single-beat, short-axis 4-D echo imaged by GE’s Vivid E9. The system also offers software to reduce the number of clicks needed for exams. Photo courtesy of GE Healthcare

Hardware and software advances are enabling echocardiography to greatly expand its capability with increased quantification accuracy, ease-of-use, increased workflow efficiencies and wider use outside of echo labs. Today, cardiovascular ultrasound systems are being integrated into point-of-care for triage, and in operating rooms and cath labs for procedural guidance to cut the use of contrast and ionizing radiation. Advances in 4-D echo are making it an enhanced tool for structural heart evaluation and visualization during procedures.

3-D, 4-D Echo Advances

3-D echo images a volume of data (similar to a computed tomography [CT] dataset) rather than the traditional 2-D image rendering. These volumes can be manipulated with advanced visualization software just like a CT, slicing images on any plane and enabling the creation of 3-D images that can be rotated.

The proliferation of 3-D echo was previously handicapped by the large amount of labor involved in creating images from a volume dataset, explained Stephen Little, M.D., FRCPC, FACC, FASE, cardiovascular imaging section, department of cardiology, Methodist DeBakey. He said earlier generation systems required 30 or 40 mouse clicks to create an image.

“3-D required a lot of manual processing to slice and dice the images. It just took too long to do anything,” Little explained.

However, he said the newer 3-D systems are making the technology more viable with automation. He said echo is following the same path previously followed by CT advanced visualization software, where automation made a big difference in its wider market adoption for daily use.

Two big technology innovations have recently made 3-D and 4-D systems more commercially viable for everyday use. First, there has been a rapid increase in computing power in less expensive, smaller packages. Second, the automation of many advanced visualization functions drastically simplifies use and reduces the staff time required to manipulate volumes.

The introduction of 4-D echo (the fourth dimension is the addition of time) has opened new possibilities in ultrasound imaging. The analogy of 4-D is the difference between video and a still photograph. The technology allows 3-D images to be continuously updated for a live video view. The platforms with this feature require very fast processors to reconstruct large volumes of data into 3-D images over and over in milliseconds.

4-D ultrasound offers several advantages. It offers real-time color flow to assess hemodynamic information in the same heart cycle. It offers very accurate qualification of the left ventricle, free of geometric and shape assumptions used in 2-D echo. By using a 3-D volume of data, left ventricular wall motion tracking analysis can be done using the raw data volumes acquired. Vendors say this increases the accuracy of quantification.

It also offers multi-dimensional imaging, where operators can simultaneously acquire bi-plane and tri-plane images from the same heartbeat without moving the probe’s position.  This offers two or three different axis views concurrently or as a composite view of the heart in real-time, offering a new field-of-view that previously could not be obtained.  This helps acquire more information in fewer steps.

Real-time 4-D can produce images that are incredibly lifelike. This makes them easier to interpret and offers more meaningful information, including better procedural guidance. As technology continues to advance, 4-D echo will offer images comparable to CT 3-D reconstructions. Surgeons are now using 3-D echo reconstructions to aid procedural planning.

Use of 4-D greatly aids assessment of congenital heart diseases. Siemens recently introduced an updated version of its SC2000 cardiac ultrasound that quantifies volumetric color blood flow when evaluating holes in the heart (ASDs, VSDs, PFOs). The system uses a 3-D representation to show the true surface area and helps estimate the size of the holes for procedural planning.

Innovations in 4-D make possible real-time, comprehensive analysis of the beating heart during the entire cardiac cycle and allows even more detailed surgical-like views of the anatomy.

Toshiba’s new Aplio 500 shows the future of 4-D, where it can reconstruct volumes into color, fly-through video of vessel lumens. It works with peripheral vessels, but the heart is still too fast for the new technology to capture coronary vessels or ventricles. Image quality is similar to CT virtual colonoscopy.

Practical Application of 3-D

Methodist DeBakey Heart and Vascular Center has its own imaging center, which uses 3-D echo extensively. The center also images patients with both magnetic resonance imaging (MRI) and 3-D echo for comparative effectiveness research.

In the echo lab, 3-D echo is very good at estimating left ventricular ejection fractions (LVEF). However, there is a need for standardization between vendors before this technology will be used mainstream, Little said. Each 3-D echo machine is slightly different, so the workflow is not the same from vendor to vendor, and each requires use of proprietary workstations.

He explained 3-D offers a more accurate picture of cardiac function, but the basic concepts of 2-D echo still apply.

“3-D is not magic. It starts with a good 2-D image and you face all the same physics challenges as you do with 2-D technology,” Little said.

At DeBakey, echo contrast is often used to improve 2-D image quality when imaging obese patients, but they found 3-D has some limitations with contrast, said Miguel A. Quiñones, M.D., MACC, chairman, department of cardiology.  The software uses automated 3-D tracking of the borders of the ventricle, he explained, but the automated tracking system is confused by the contrast and has issues. However, an operator can overcome this by switching to a manual mode.

Little said hospitals need to assess whether there is a need for 3-D. “It depends on what they plan to do with the system. If you plan to use it for surgical procedures, then it might be worth investing in a 3-D system. If you are involved in activities with more emphasis on structural heart, then 3-D has a lot of application.”

Expanding TEE Use

Little said DeBakey makes extensive use of 3-D echo transesophogeal echo (TEE) to better guide mitral valve prolapse and regurgitation repairs, atrial septal defects (ASDs) and trans-aortic valve repair (TAVR). In TAVR, he said  TEE helps accurately place the angiographic pigtail catheter in the non-coronary cusp of the aortic root.  It also offers Doppler flow imaging to evaluate the hemodynamics of the valves and check for paravalvular leaks.

Little explained 3-D TEE offers a definite imaging advantage during complex interventions. The use of an X-plane (also referred to as bi-plane) TEE probe allows visualization from two different angles. He said these views are displayed on the main screen in a cath lab or hybrid OR to better visualize where a catheter or device is located in the anatomy more clearly than 2-D angiography. This helps with procedural navigation and in cutting the radiation dose from fluoroscopy.

“You can get two views simultaneously from two different perspectives, which helps speed things up,” Little said. “It adds a level of confidence to show you where wires and devices are inside the heart.”

DeBakey uses 3-D echo from various vendors, including Philips, GE and Siemens, but only the Philips system had offered 3-D TEE, Little said.

Siemens recently introduced syngo FourSight 3-D TEE. It can scan the whole heart in one volume instead of stitching two or three images to create a whole-heart image.

GE Healthcare also has a new 4-D  TEE system pending FDA review, which it previewed as a work-in-progress in March at American College of Cardiology (ACC) 2012 .

Comparison Chart

This article served as an introduction to the cardiovascular ultrasound systems comparison chart in the May-June 2012 issue of DAIC. Participants included:

Esaote North America –http://www.esaoteusa.com

GE Healthcare – http://www.gehealthcare.com

Mindray – http://www.mindray.com

Philips – http://www.philips.com

Siemens – http://www.medical.siemens.com

Toshiba – http://www.medical.toshiba.com

SOURCE:

http://www.dicardiology.com/article/3-d-4-d-enhancements-may-be-future-ultrasound

New Software to aid Interventional Cardiologists and Cardiac Surgeons in TAVI Procedures.

We covered the procedure and the technologies in the following curated article:

Clinical Trials on transcatheter aortic valve replacement (TAVR) to be conducted by American College of Cardiology and the Society of Thoracic Surgeons

http://pharmaceuticalintelligence.com/2013/02/12/american-college-of-cardiologys-and-the-society-of-thoracic-surgeons-entrance-into-clinical-trials-is-noteworthy-read-more-two-medical-societies-jump-into-clinical-trial-effort-for-tavr-tech-f/

TAVI Planning Software Introduced

Software enables selection of patients and access routes; aids procedure navigation, annulus sizing

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Written By:

Dave Fornell

February 1, 2012

Philips received FDA clearance in December 2011 for its Heart Navigator TAVI planning and image guidance tool.

With the approval of the Sapien valve in November 2011, transcatheter aortic valve implantation (TAVI) technology is expected to revolutionize heart valve replacement with a minimally invasive procedure to replace open-heart surgery. However, it requires a good deal of planning, sizing and anatomical assessment of access routes using computed tomography (CT) scans with manipulation by advanced visualization software.

The success of this new procedure depends on correct patient selection and reliable pre-operative planning. In the conventional procedure, the necessary measurements are made during the actual surgery under direct visualization, but with TAVI, this can only be done pre-operatively with the aid of image data. A clear appreciation of the involved anatomy is crucial, and due to the fact that aortic anatomy is complex, 3-D visualization and measurement tools may enable more accurate and efficient pre- and post-intervention planning, which can be further enhanced with stereoscopic 3-D.At the 2011 Radiological Society of North America (RSNA) annual meeting, TeraRecon and Qi Imaging (formerly Ziosoft) both unveiled  TAVI planning and tool set software packages. The software helps automate manipulation of a CT dataset to quickly extract only the anatomy of interest and measurements, such as sizing of the aortic valve annulus and evaluation of clearance between the new valve and the right and left main coronary arteries. The software helps evaluate the aortic anatomy of patients to see if the route is clear for the larger delivery catheters required for the procedure. A heavily calcified aorta may disqualify a patient from the femoral access route.
Qi Imaging applied its super-computing, deformable registration software to its TAVI package, allowing lifelike motion of the cardiac cycle. This may offer a more accurate assessment of the motion of annulus for better valve sizing.
Philips Healthcare received FDA clearance in December for its HeartNavigator procedure planning and image guidance tool to help perform minimally invasive heart valve replacements. The technology merges pre-operatively acquired 3-D CT scans of the patient’s heart with the live interventional X-ray views. Using this technology, physicians can now simultaneously see the detailed 3-D anatomy of the patient’s heart together with the positioning of the catheter and the placement and deployment of the artificial valve.
TAVI has been available in Europe since March 2010. In August 2010, Siemens introduced its syngo Aortic ValveGuide in Europe to aid in TAVI procedures. It uses rotational angiography dataset images in the hybrid OR to help surgeons and interventional cardiologists navigate during transcatheter valve implantations. The software processes CT-like images of the heart from images acquired with the angiography system and creates 3-D overlay images on the live fluoroscopy. The software also finds the correct optimal C-arm angulation with a perpendicular view on the aortic root.

• 
  Siemens’ syngo Aortic ValveGuide aids TAVI navigation with rotational angiography image overlays.

SOURCE:

 http://www.dicardiology.com/article/tavi-planning-software-introduced

MORE LIKE THIS

• FDA Clears Philips’ HeartNavigator Interventional Visualization Tool
• TAVI Planning Software Introduced
• Philips Showcases Advanced Imaging Integration in Electrophysiology at Boston Atrial Fibrillation Symposium 2013
• The Latest Cardiovascular Imaging Technology
• 3-D, 4-D Enhancements May Be the Future of Ultrasound

 

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Clinical Trials on Transcatheter Aortic Valve Replacement (TAVR) to be conducted by American College of Cardiology and the Society of Thoracic Surgeons

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Bio Instrumentation in Experimental Life Sciences Research, Cardiac & Vascular Repair Tools Subsegment, Ecosystems & Industrial Concentration in the Medical Device Sector, FDA Regulatory Affairs, Frontiers in Cardiology and Cardiovascular Disorders, Health Economics and Outcomes Research, Health Law & Patient Safety, Interviews with Scientific Leaders, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Valves & Tools, tagged ACC, Clinical trial, Edwards, FDA, Food and Drug Administration, Medtronic, St. Jude Medical, STS on February 12, 2013| 5 Comments »

Clinical Trials on Transcatheter Aortic Valve Replacement (TAVR) to be conducted by American College of Cardiology and the Society of Thoracic Surgeons

Curator: Aviva Lev-Ari, PhD, RN

WordCloud Image Produced by Adam Tubman

UPDATED on 6/22/2017

• by Nicole Lou, Reporter, MedPage Today/CRTonline.org June 21, 2017

Action Points

• Off-label transcatheter aortic valve replacement (TAVR) was associated with higher in-hospital, 30-day, and 1-year mortality rates compared with on-label TAVR use, but after adjustment, 1-year mortality was similar in the two groups.
• Note that approximately one in 10 TAVR patients in the United States have received the procedure for an off-label indication.

SOURCE

1 in 10 TAVR Procedures Done Off-Label Despite early risks vs on-label use, ‘acceptable results’ cited from registry

• Reviewed by Henry A. Solomon, MD, FACP, FACC  Cinical Associate Professor, Weill Cornell Medical College and Dorothy Caputo, MA, BSN, RN, Nurse Planner

https://www.medpagetoday.com/Cardiology/CHF/66173?xid=nl_mpt_DHE_2017-06-22&eun=g99985d0r&pos=1

• Primary Source

  JAMA Cardiology

  Source Reference: Hira RS, et al “Trends and outcomes of off-label use of transcatheter aortic valve replacement: insights from the NCDR STS/ACC TVT Registry” JAMA Cardiol 2017; DOI: 10.1001/jamacardio.2017.1685.

• Secondary Source

  JAMA Cardiology

  Source Reference: Joynt KE and Kramer DB “Off-label use of high-risk cardiovascular devices: widening the lens” JAMA Cardiol 2017; DOI: 10.1001/jamacardio.2017.1732.

• Additional Source

  JAMA Cardiology

  Source Reference: Califf RM “Evaluating evolving technologies in a time of rapid change: the case of transcatheter aortic valve replacement” JAMA Cardiol 2017; DOI: 10.1001/jamacardio.2017.1733.

UPDATED on 11/24/2013

Second Generation Transcatheter Aortic Valve Shown to Successfully Address TAVR Complications

Results of the REPRISE II trial reported at TCT 2013

November 4, 2013

November 4, 2013 — In a clinical trial of the Boston Scientific Lotus valve, a second-generationtranscatheter aortic valve, the device demonstrated low rates of complications that are sometimes seen in transcatheter aortic valve replacement (TAVR), including challenges with positioning, post-procedure paravalvular aortic regurgitation, vascular complications and stroke.

The findings were presented at the 25th annual Transcatheter Cardiovascular Therapeutics scientific symposium (TCT 2013).

The valve studied in REPRISE II is fully retrievable and repositionable with an adaptive seal intended to minimize paravalvular regurgitation, a complication that has been associated with higher mortality among patients undergoing TAVR. In this prospective, single-arm, multicenter study, symptomatic patients at high risk for surgery received the Lotus valve to treat calcific aortic stenosis.

The trial enrolled 120 patients; mean age was 84.4±5.3 years, 56.7 percent were female and 75.8 percent were considered New York Heart Association (NYHA) Class III or IV. The mean Society of Thoracic Surgeons score was 7.1±4.6 percent and all patients were confirmed by their site heart team to be at high risk for surgery due to frailty or associated comorbidities.

The valve was successfully implanted in all 120 patients with valve repositioning and retrieval performed as needed. There was no embolization, ectopic valve deployment or need for implantation of a second prosthetic valve.

The primary device performance endpoint was the mean aortic valve pressure gradient at 30 days compared to a performance goal of 18 mmHg; the primary safety endpoint was 30-day mortality. The primary device performance endpoint was met with a 30 day mean aortic valve pressure gradient of 11.5±5.2 mmHg; mean effective orifice area was 1.7±0.4 cm2.

All cause mortality and disabling stroke were low at 30 days (4.2 percent and 1.7 percent, respectively). Additional clinical event rates were consistent with those reported for other valves. Aortic regurgitation at 30 days was negligible in 99 percent of patients (78.3 percent none, 5.2 percent trace and 15.5 percent mild). The total stroke rate, disabling and non-disabling, was 5.9 percent, which is the same as the rate as the Edward’s Sapien valve’s performance in the PARTNER trial.

“These findings suggest this valve, which is a differentiated, second generation TAVR device, will be a valuable addition for the treatment of severe aortic stenosis,” said Ian Meredith, MBBS, Ph.D., director, Monash HEART, executive director, Monash Cardiovascular Research Centre, professor of medicine, Monash University in Melbourne, Australia, and lead investigator of the study.

For more information: http://www.crf.org, http://www.bostonscientific.com

MORE LIKE THIS

• Favorable Six-Month Results Reported From Lotus Valve Clinical Trial
• Boston Scientific Announces Positive Data From Lotus Transcatheter Aortic Valve Trial
• First Patient Enrolled in REPRISE II TAVR Trial to Evaluate Lotus Valve
• Boston Scientific Lotus Valve System Meets Primary Performance Endpoint in REPRISE II Trial
• Lotus Valve TAVI System Shows Good Performance in REPRISE II Trial

SOURCE

http://www.dicardiology.com/article/second-generation-transcatheter-aortic-valve-shown-successfully-address-tavr-complications?goback=%2Egde_675087_member_5803962928159797249#%21

“This is the first time the societies have ever filed for an investigational device exemption,” former ACC president Ralph Brindis is quoted as saying. “The goal of the effort is to gain reimbursement for an expanded set of procedures with Sapien to make the device accessible to more patients.”

Two medical societies jump into clinical trial effort for TAVR tech – FierceMedicalDevices http://www.fiercemedicaldevices.com/story/two-medical-societies-jump-clinical-trial-effort-tavr-tech/2013-02-12#ixzz2Kjk7MHEi

The new trials will mean that reimbursement will now be possible for some of these uses when patients are enrolled in the clinical trials. According to Mack, the NCD “took off-label use off the table. If you are a cynic this is good, but if you’re a practitioner this is tying your hands.”

http://www.forbes.com/sites/larryhusten/2013/02/12/two-medical-societies-break-new-ground-to-test-medical-device/

According to Forbes, STS president Michael Mack told The Gray Sheet (a subscription-only publication) that the first trial will look at alternatives to transfemoral approaches in 1,000 patients who couldn’t otherwise have aortic valve surgery. There was a coordinated effort to develop a trial protocol, worked out between the CACC, STS, CMS, Edwards and the FDA. Expanded uses require an FDA label, he noted, and the only way to do that is to conduct a clinical trial with an IDE in hand.

So why would expanded TAVR uses be necessary? Well, the procedure has become very much in demand, and physicians already began pursuing off-label uses once they learned the initial TAVR procedure, Brindis told Forbes. The magazine notes that the entrance of both the STS and ACC into TAVR clinical trials greatly expands the TVT registry that they run, which tracks TAVR use in the United States to help physicians comply with Medicare’s National Coverage Decision for TAVR.

TAVR is indeed a hot space. St. Jude Medical ($STJ) won a CE mark for its Portico transcatheter heart valve late last fall, and Edwards’ Sapien competes with Medtronic‘s ($MDT) CoreValve in Europe. And smaller companies such as Micro Interventional Devices are working hard to develop surgical tools designed to enable TAVR procedures.

Brindis and Mack said that the ACC and STS worked closely with CMS,the FDA, and Edwards to develop the trial protocol. In the trial, patients not eligible for aortic valve surgery will receive TAVR through transapical and transaortic approaches and will be compared with the results of patients in the original PARTNER A trial who received TAVR through the transapical approach. Mack concedes that the trial design is not idea. “There is no perfect comparator,” he acknowledged.

http://www.forbes.com/sites/larryhusten/2013/02/12/two-medical-societies-break-new-ground-to-test-medical-device/

Other experts in the field contacted by CardioBrief agreed that the challenges of trial design in this situation are quite formidable. Randomized trials are not always feasible and, in some situations, may be unethical. The IDE is an attempt to balance the need for rational clinical trials, on the one hand, and the growing pressure to perform off-label procedures. It should be noted that an important safeguard for patients remains in place: all potential TAVR patients will still need to be evaluated by both a cardiologist and a cardiac surgeon as part of the “heart team” approach mandated by the FDA and the NCD.

http://www.forbes.com/sites/larryhusten/2013/02/12/two-medical-societies-break-new-ground-to-test-medical-device/

The ACC and STS are now working to gain FDA approval to perform two more studies. One would examine the role of alternative approaches in the high-risk population eligible for surgery. The second would study valve-in-valve TAVR procedures. Both studies also present challenging problems of trial design. Mack said he anticipates FDA approval of these protocols in the next few months.

Edwards agreed in principle to fund the clinical trials. An Edwards representative confirmed that the company planned to support these new trials, but the details have not yet been hammered out.

 Mack states that the power and scope of the TVT registry actually makes it easier for ACC and STS to move forward than Edwards. Further, Mack believes that some indications are like “orphan” indications that are medically but not commercially compelling.

http://www.forbes.com/sites/larryhusten/2013/02/12/two-medical-societies-break-new-ground-to-test-medical-device/

Two medical societies jump into clinical trial effort for TAVR tech – FierceMedicalDevices http://www.fiercemedicaldevices.com/story/two-medical-societies-jump-clinical-trial-effort-tavr-tech/2013-02-12#ixzz2KjheTKHN

Larry Husten, wrote on  5/04/2012 in Forbes,  The final decision earlier this week by the Centers for Medicare & Medicaid Services (CMS) to provide reimbursement for TAVR was the latest step in a long, ongoing process that, for once, didn’t appear broken, and, in fact, represented an unusual consensus among physicians, regulators, insurers, and other involved parties In his article

Politics and Transcatheter Aortic Valve Replacement

From the first early stages of its development, the prospect of transcatheter aortic valve replacement (TAVR) provoked two broad and competing fears:

1. Regulatory safeguards would kill a promising new technology, denying its life-saving benefits to many thousands of desperately sick people.
2. The stampede to stake a claim in a promising, highly lucrative new territory would lead to the exploitation and mistreatment of many thousands of desperately sick people.

http://www.forbes.com/sites/larryhusten/2012/05/04/politics-and-transcatheter-aortic-valve-replacement/

Scott Gottlieb, a conservative activist who is a former FDA deputy commissioner and CMS adviser, concludes that the CMS ruling means “that for costly procedures, Washington will be making more of these choices for us.” In a posting on the American Enterprise Institute’s The Enterprise Blog, Gottlieb writes that the decision “is a vivid example of how our healthcare is going to get reimbursed now that Washington calls more of the shots.”

http://www.forbes.com/sites/larryhusten/2012/05/04/politics-and-transcatheter-aortic-valve-replacement/

CMS  has insisted that doctors who perform the procedure have adequate training and that the hospitals where the procedures are performed have sufficient experience and adequate facilities. Perhaps Scott Gottlieb, MD would be happy to send an elderly relative for TAVR  to a local community hospital with little experience in the procedure. It was precisely to avoid this scenario that the American College of Cardiology and the Society of Thoracic Surgeons supported CMS in this coverage decision. I fail to see how anyone would benefit by widespread proliferation of TAVR by novice operators at inexperienced centers.

• Physicians,
• Regulators,
• Insurers,
• CMS,
• Medical Device Manufactures
• ACC, and
• STS

will be cooperating in the College of Cardiology and Society of Thoracic Surgeons newly announced involvement in Clinical Trials on broader use of transcatheter aortic valve replacement (TAVR) procedure to include new patients that this procedure will be indicated for and CMS reimbursed.

Other aspects of the Procedure, and the role EdwardsSciences played in the development and the Industry Leadership it holds in the US, are covered in several articles on this Open Access Online Scientific Journal, including the following:

August 7, 2012 – Transcatheter Aortic Valve Implantation (TAVI): risk for stroke and suitability for surgery

http://pharmaceuticalintelligence.com/2012/08/07/transcatheter-aortic-valve-implantation-tavi-risky-and-costly-2/

August 2, 2012 – Transcatheter Aortic Valve Implantation (TAVI): Risky and Costly

http://pharmaceuticalintelligence.com/2012/08/02/transcatheter-aortic-valve-implantation-tavi-risky-and-costly/

June 4, 2012 – Investigational Devices: Edwards Sapien Transcatheter Aortic Valve Transapical Deployment http://pharmaceuticalintelligence.com/2012/06/04/investigational-devices-edwards-sapien-transcatheter-heart-valve/

June 10, 2012 — Investigational Devices: Edwards Sapien Transcatheter Aortic Heart Valve Replacement Transfemoral Deployment http://pharmaceuticalintelligence.com/2012/06/10/investigational-devices-edwards-sapien-transcatheter-aortic-heart-valve-replacement-transfemoral-deployment/

June 19, 2012 — The Centers for Medicare & Medicaid Services (CMS) covers transcatheter aortic valve replacement (TAVR) under Coverage with Evidence Development (CED) http://pharmaceuticalintelligence.com/2012/06/19/the-centers-for-medicare-medicaid-services-cms-covers-transcatheter-aortic-valve-replacement-tavr-under-coverage-with-evidence-development-ced/

1/29/2013 — Direct Flow Medical Wins European Clearance for Catheter Delivered Aortic Valve

http://pharmaceuticalintelligence.com/2013/01/29/direct-flow-medical-wins-european-clearance-for-catheter-delivered-aortic-valve/

6/19/2012 Executive Compensation and Comparator Group Definition in the Cardiac and Vascular Medical Devices Sector: A Bright Future for Edwards Lifesciences Corporation in the Transcatheter Heart Valve Replacement Market

http://pharmaceuticalintelligence.com/2012/06/19/executive-compensation-and-comparator-group-definition-in-the-cardiac-and-vascular-medical-devices-sector-a-bright-future-for-edwards-lifesciences-corporation-in-the-transcatheter-heart-valve-replace/

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Direct Flow Medical Wins European Clearance for Catheter Delivered Aortic Valve

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Cardiac & Vascular Repair Tools Subsegment, Ecosystems & Industrial Concentration in the Medical Device Sector, FDA Regulatory Affairs, FDA, CE Mark & Global Regulatory Affairs: process management and strategic planning - GCP, GLP, ISO 14155, Frontiers in Cardiology and Cardiovascular Disorders, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Medical Imaging Technology, Image Processing/Computing, MRI, CT, Nuclear Medicine, Ultra Sound, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Valves & Tools, tagged Aortic valve, Catheter, CE mark, Direct Flow Medical, Inflatable on January 29, 2013| 6 Comments »

Direct Flow Medical Wins European Clearance for Catheter Delivered Aortic Valve

Reporter: Aviva Lev-Ari, PhD, RN

UPDATED on 7/15/2018

Direct Flow Medical, which markets a CE-marked transcatheter aortic valve implantation (TAVI) device, has closed after funding from a Chinese pharmaceutical company did not come through. According to newspaper The Press Democrat, all 250 company’s employees have been made redundant and it officially ceased trading on 30 November.

The paper reports that Direct Flow’s former president and chief executive officer Dan Lemaitre, in a phone interview, told them the company had expected an influx of funding from a Chinese pharmaceutical company on 18 November but the deal collapsed two days before the money was scheduled to arrive. Lemaitre said this was because “the terms of which were changed dramatically in a very unacceptable fashion.”

The Press Democrat claims that the 12-year-old company had no other options and its lender—PDL BioPharma Inc—refused to extend the US$65 million funding arrangement it had with Direct Flow for the past three years and foreclosed upon the business.

SOURCE

https://cardiovascularnews.com/tavi-company-direct-flow-medical-closes-after-failing-to-secure-funding/

 

TAVI company Direct Flow Medical closes after failing to secure funding

16th January 2017

 

Catheter Delivered Aortic Valve from Direct Flow Medical Wins European Clearance (w/video)

by GENE OSTROVSKY on Jan 28, 2013 • 1:32 pm

Having unveiled attractive results of a study on its transcatheter aortic valve, Direct Flow Medical (Santa Rosa, CA) has just announced CE Mark approval for the device. The polymer frame prosthesis sits on top of the diseased natural valve with its inflatable rings guaranteeing contact along the perimeter.

Since the new valve only uses physical pressure from the inflatable rings to hold on, it can be repositioned at any time or removed completely if necessary.

Here’s more about the valve from its product page:

The bovine pericardial leaflets are attached to an inflatable polyester fabric cuff which conforms to the native aortic valve annulus and left ventricular outflow tract to form a seal to minimize the potential of paravalvular leak. The Bioprosthesis is designed with independently inflatable ventricular and aortic rings, which encircle and capture the native valve annulus to provide positive axial anchoring of the device. Inflation of the cuff with a saline and contrast solution renders the valve immediately functional and permits fluoroscopic visualization. Before final deployment, the saline and contrast mixture is exchanged under pressure, maintaining cuff shape and position, with a solidifying Polymer that hardens to form the permanent support structure.

 

WATCH VIDEO 

Direct Flow Medical: Transcatheter Aortic Valve

 

Flashback: Direct Flow Medical Transcatheter Aortic Valve Does Well in Clinical Study

Product page: Direct Flow Medical Transcatheter Aortic Valve System…

SOURCE:

http://www.medgadget.com/2013/01/catheter-delivered-aortic-valve-from-direct-flow-medical-wins-european-clearance-wvideo.html?

http://www.medgadget.com/2013/01/catheter-delivered-aortic-valve-from-direct-flow-medical-wins-european-clearance-wvideo.html?goback=%2Egde_4346921_member_205701983%2Egmr_675087%2Eanp_675087_1359500095698_1%2Egmr_675087%2Egde_675087_member_208816811%2Egmr_675087

Other articles related to this topics were published on this Open Access Online Scientific Journal, include the following:

August 7, 2012 – Transcatheter Aortic Valve Implantation (TAVI): risk for stroke and suitability for surgery

http://pharmaceuticalintelligence.com/2012/08/07/transcatheter-aortic-valve-implantation-tavi-risky-and-costly-2/

August 2, 2012 – Transcatheter Aortic Valve Implantation (TAVI): Risky and Costly

http://pharmaceuticalintelligence.com/2012/08/02/transcatheter-aortic-valve-implantation-tavi-risky-and-costly/

June 4, 2012 – Investigational Devices: Edwards Sapien Transcatheter Aortic Valve Transapical Deployment http://pharmaceuticalintelligence.com/2012/06/04/investigational-devices-edwards-sapien-transcatheter-heart-valve/

June 10, 2012 — Investigational Devices: Edwards Sapien Transcatheter Aortic Heart Valve Replacement Transfemoral Deployment http://pharmaceuticalintelligence.com/2012/06/10/investigational-devices-edwards-sapien-transcatheter-aortic-heart-valve-replacement-transfemoral-deployment/

 June 19, 2012 — The Centers for Medicare & Medicaid Services (CMS) covers transcatheter aortic valve replacement (TAVR) under Coverage with Evidence Development (CED) http://pharmaceuticalintelligence.com/2012/06/19/the-centers-for-medicare-medicaid-services-cms-covers-transcatheter-aortic-valve-replacement-tavr-under-coverage-with-evidence-development-ced/

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FDA Pending 510(k) for The Latest Cardiovascular Imaging Technology

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Atherogenic Processes & Pathology, CABG, Cardiac & Vascular Repair Tools Subsegment, Ecosystems & Industrial Concentration in the Medical Device Sector, FDA Regulatory Affairs, FDA, CE Mark & Global Regulatory Affairs: process management and strategic planning - GCP, GLP, ISO 14155, Frontiers in Cardiology and Cardiovascular Disorders, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Medical Imaging Technology, Image Processing/Computing, MRI, CT, Nuclear Medicine, Ultra Sound, Mitral Valve: Repair and Replacement, PCI, Personalized and Precision Medicine & Genomic Research, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, Renal Denervation, Statistical Methods for Research Evaluation, Technology Transfer: Biotech and Pharmaceutical, tagged Center for Devices and Radiological Health, Critical Path Institute, FDA, Food and Drug Administration, MDIC, Medical device, Public–private partnership, Regulatory science on January 28, 2013| 16 Comments »

FDA Pending 510(k) for The Latest Cardiovascular Imaging Technology

Curator: Aviva Lev-Ari, PhD, RN

 

UPDATED on 11/22/2018

• Device Approvals, Denials and Clearances

https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/default.htm

• FDA clears AI technology that evaluates echocardiograms – Ultrasound Images

https://www.healthdatamanagement.com/news/fda-clears-ai-technology-that-evaluates-echocardiograms

• Heart Murmur Detection done by AI Algorithm (Eko Core and Eko Duo) Devices Outperform most Auscultatory Skills of Cardiologists

https://pharmaceuticalintelligence.com/2018/11/21/heart-murmur-detection-done-by-ai-algorithm-eko-core-and-eko-duo-devices-outperform-most-auscultatory-skills-of-cardiologists/

• FDA Clears Remote Multichannel ECG Compared to Holter

https://www.cardiovascularbusiness.com/topics/electrophysiology-arrhythmia/fda-clears-remote-multichannel-ecg-compared-holter

• Arterys Cardio AI – MR Images

Arterys CEO Fabien Beckers, along with Michael Poon, MD, Northwell Health cardiologist, will present “The Potential of a Web Platform to Transform Medical Imaging with AI and Cloud Computation” in the 2018 RSNA Machine Learning Showcase, Tuesday November 27 at 11:30am CST. Arterys will provide demonstrations of its AI-powered, web-based solutions, including:

Arterys Cardio AIMR combines the power of deep learning and cloud computing to automate analysis of cardiac MR images. By eliminating many tedious, manual tasks, Arterys Cardio AI enables clinicians to quickly and easily identify, determine treatment for and track heart problems. It is the first and only commercial solution to offer deep learning-based semi-quantitative perfusion and quantitative delayed enhancement analysis*.

https://www.marketwatch.com/press-release/arterys-to-demonstrate-suite-of-ai-powered-cloud-based-medical-image-analysis-solutions-at-rsna-2018-2018-11-21/print

• AI software for detecting brain bleeds receives FDA approval – CT Images

November 08, 2018 | Melissa Rohman | Artificial Intelligence

The FDA recently administered 510(k) clearance to software developed by MaxQ AI that uses AI to detect brain bleeds on CT images, according to a report published Nov. 8 by AI in Healthcare.  

“The Accipio Ix Intracranial Hemorrhage platform uses AI technology to automatically analyze non-contrast head CT images, and can do so without impacting a physician’s workflow, altering the original series or storing protected health information,” according to the article.

The clinical diagnostics intelligence platform company hopes that the software can help physicians prioritizes patients who show symptoms of brain bleeds.

With FDA approval, the AI software can be sold for commercial use within the U.S. and will be on display during this year’s Radiological Society of North America (RSNA) Annual Meeting in Chicago.

https://www.healthimaging.com/topics/artificial-intelligence/ai-detection-software-brain-bleeds-fda-approved

 

• More in Artificial Intelligence

Chest x-ray AI similar, but quicker than radiologists at detecting diseases

AI may help radiologists interpret screening mammography without added reading time

Predictive model may reduce overtreatment of ground glass nodules

Philips launches IntelliSpace Discovery* Research platform at RSNA to support the development and deployment of Artificial Intelligence assets in radiology

Machine learning method helps radiologists diagnose uterine cancer

Radiomics, AI fall short of radiologists in breast lesion classification on MRI

New trial may allow CMAs to perform echocardiograms with AI-guided ultrasound

CDS tool improves reader diagnosis of bladder cancer response to treatment

AI estimates full-dose PET images from low-dose scans

Australian university hopes digital pathology method can address pathologist shortage

SOURCE

https://www.healthimaging.com/topics/artificial-intelligence/ai-detection-software-brain-bleeds-fda-approv

Cardiovascular Medical Devices in the News

• 3D printing can identify device size for LAA occlusion
  

March 13, 2018 — Determining the best occluder device size necessary to properly seal the left atrial appendage (LAA) before implanting the device may be feasible with the assistance of 3D printing, according to two separate presentations at ECR 2018 in Vienna.

SOURCE

https://www.auntminnieeurope.com/index.aspx?sec=sup&sub=car&pno=2

• Machine learning can help assess atherosclerosis
  February 7, 2018 — Machine-learning techniques analyze imaging measurements to automatically stratify patients by the level of atherosclerotic burden, offering the potential of personalized prediction of disease progression and more effective treatment for individual patients, according to researchers from Italy.  Discuss

SOURCE

https://www.auntminnieeurope.com/index.aspx?sec=sup&sub=car&pno=3

• CCTA biomarker may predict mortality from heart disease
  August 28, 2018 — The use of coronary CT angiography (CCTA) to measure fatty tissue around arteries could help predict the risk of mortality from heart disease, according to research published online on 28 August in the Lancet and being presented at the European Society of Cardiology congress in Munich.  Discuss

SOURCE

https://www.auntminnieeurope.com/index.aspx?sec=sup&sub=car&pno=1

• SCOT-HEART: CCTA cuts risk of heart attack, death by 41%
  August 25, 2018 — Patients with chest pain who underwent coronary CT angiography (CCTA) with standard care had a markedly lower rate of myocardial infarction or death from coronary artery disease than those who only received standard care in a new study, published on August 25 in theNew England Journal of Medicine.  Discuss

SOURCE

https://www.auntminnieeurope.com/index.aspx?sec=sup&sub=car&pno=1

 

• Indiana University Health adds CT scans to 911 calls for stroke

  

  Emergency response service aims to pinpoint cause of brain injury and speed correct treatment to patients.

  RadiologyDiana Manos April 26

• Brain MRI images can predict cognitive function after heart attack

  

  Assessment finds which patients may respond best to treatment and fully recover from post-attack comas.

  RadiologyMarla Durben HirschApril 23

• Device able to quickly and accurately detect stroke

  

  Neurologic assessment sends radio waves through the brain in a scanning process that takes just 30 seconds.

  RadiologyGreg Slabodkin April 2

• Geisinger taps EHR, genomics to identify high-risk patients

  

  The provider may make the MyCode Community Health Initiative and its DNA sequencing a part of routine care.

  Genome sequencingGreg Slabodkin March 23

• Smartwatch app accurately detects atrial fibrillation

  

  Cleveland Clinic study shows ECG algorithm reliably differentiates between AFib and normal heart rhythm.

  Wearable technologyGreg Slabodkin March 2

• Algorithm uses EHR data to identify undiagnosed hypertension patients

  

  Leveraging clinical data increases accuracy, efficiency of identifying and diagnosing high blood pressure.

  EHR analysisGreg SlabodkinFebruary 27

• VA leverages EHR data to assess care quality for mini-stroke patients

  

  Agency uses electronic process measures to evaluate patients after transient ischemic attacks instead of manual chart review.

 

SOURCE

https://www.healthdatamanagement.com/tag/cardiovascular-disease

FDA’s Medical Devices Frontier in 2013

Michelle McMurry-Heath

Office of the Center Director, Center for Devices and

Radiological Health, U.S. Food and Drug Administration (FDA)

and

Margaret A. Hamburg

Office of the Commissioner, FDA

In their article Creating a Space for Innovative Device Development stated that the FDA announces a partnership with a new nonprofit organization—the Medical Device Innovation Consortium (MDIC) —to advance regulatory science in the medical technology arena.

The promise of MDIC is to eliminate the currently existing shortfalls in applied research in areas such as health-related engineering and regulatory science, which comprises the development of new tools, standards, and approaches to assess a product’s safety, efficacy, quality, and performance.

MDIC will foster regulatory science breakthroughs in the medical technology space with the ultimate goal of improving human health.

FDA and LifeScience Alley (LSA; https://www.lifesciencealley.org)—a biomedical science trade association—have worked together to develop the first medical device public-private partnership (PPP) whose sole objective is to advance the entire spectrum of regulatory science in this sector. MDIC will facilitate this groundbreaking collaboration among federal agencies, nonprofit organizations, industry, academic institutions, and other trade associations such as MassMedic (www.massmedic.com) and the California Healthcare Institute (www.chi.org). Key goals:

(1) encourage members to leverage their resources by focusing jointly on precompetitive

(2) early-stage technology development ef orts that otherwise would not take place because of the organizational structure of the device sector.

About 75% of the more than 5,000 device manufacturers in the United States are small companies with fewer than 20 employees (3).

Start-up device companies have limited capital, and a startup’s future of en depends on the success of one complex device. Advances in regulatory science would speed the translation of these next-generation technologies.

Medical Devices sector lacks the resources to support regulatory science research, as well as mechanisms for working together to pool their resources to solve scientific issues.

MDIC members will make it a priority to develop regulatory methods and tools that can be adopted by the medical device community and will provide a forum for medical device stakeholders to securely share proprietary precompetitive data. Each advance achieved by medical device stakeholders through the sharing and leveraging of resources will assist industry in developing new REGULATORY SCIENCE Creating a Space for Innovative Device Development.

GOALS OF PARTNERING WITH MDIC

MDIC was designed with f exibility in mind, so that it can adapt to address the most pressing needs of patients and of the device industry as they evolve over time.

In keeping with the goal of stakeholder engagement, MDIC is currently recruiting founding members who will work jointly with FDA to determine research priorities for the endeavor.

Much like other successful PPPs in the pharmaceutical space, such as the Foundation for NIH or Critical Path Institute, the founding members will be asked to represent their stakeholder communities in

(i) suggesting the most promising areas for research collaboration,

(ii) raising funds to support these areas of investigation, and then

(iii) issuing requests for grant proposals.

Researchers and engineers from all sectors—industry, government, academia, or nonprofit organizations—will be encouraged to apply, and preference will be given to research consortia that cross sectors and take interdisciplinary approaches to problems.

MDIC strives to support science conducted by research teams that have innovative ideas for the development of tools and methods for medical device design, testing, and regulatory approval.

MDIC’s potential to improve patient care is computational modeling and simulation of human pathophysiology, which can be used to augment in vitro and animal disease models in the preclinical stages of device development.

FDA’s Center for Devices and Radiological Health (CDRH) expects computational modeling to accelerate and streamline the regulatory review process but first needs to develop a strategy for assessing the technology’s credibility—its usefulness, quality, and reproducibility. CDRH has begun to develop a technological framework called the Virtual Physiological Patient (4), which, once completed, will provide a model for the human body as a single complex system. 

However, cross-sector research teams are required to develop the normal and diseased reference models that will serve as benchmarks for device performance and safety. Using computational modeling and simulation, device designs can potentially be ref ned even before they enter clinical trials, improving safety for patients and reducing the cost of device development for companies, computational modeling and simulation, device designs can potentially be ref ned even before they enter clinical trials, improving safety for patients and reducing the cost of device development for companies.

Another emerging research area is medical device interoperability—the development of devices that seamlessly operate with other medical devices and information systems (5). MDIC could establish a framework to identify gaps in the interoperability field, prioritize the gaps, and then fund research accordingly.

MDIC also could help prioritize the development of standards for innovative interoperable medical devices and build test beds for these technologies. is research will help to ensure that interoperability issues do not pose a hazard to patients.

With the emergence of new materials in medical devices, FDA must develop updated biocompatibility standards based on the most recent scientific advances.

MDIC could support the development of new preclinical biocompatibility assays that predict potential adverse health responses in people exposed to biomaterials or nanoparticles (6).

INNOVATION INFRASTRUCTURE With today’s fiscal realities, FDA cannot rely on government-funded “Manhattan projects” to bridge the funding gap for regulatory science. Partnerships bring together private-sector expertise, academic science ingenuity, and federal regulatory knowledge, and new structures are needed to promote these multifaceted collaborations.

It would be convenient if such partnerships formed organically, but all too of en, bureaucratic red tape gets in the way of sensible scientif c collaboration. MDIC will serve as a collaborative freeway to biomedical discovery and development by forming a foundation that makes it easy for industry, academia, and government to come together to set research priorities; to pool their distinct intellectual capital; and then to work together to advance knowledge that modernizes regulatory science and improves patient access to high-quality medical technology.

Sci. Transl. Med. 4, 163fs43 (2012). 

[ScienceTranslationalMedicine.org 5 December 2012 Vol 4 Issue 163 163fs43]

Statistics on Device use — Number of procedures in the United States (2009)

Number of domestic inpatient procedures (N = 48 million per year)

• Insertion of coronary artery stent: 528,000
• Diagnostic ultrasound: 902,000
• CT scan: 497,000
• Arteriography and angiocardiography: 1.9 million
• Cardiac catheterization: 1.1 million
• Total hip replacement: 327,000
• Total knee replacement: 676,000

Source:

U.S. Centers of Disease Control www.cdc.gov/nchs/fastats/insurg.htm

This sector is best known for

• surgical instruments,
• cardiology devices, and
• orthopedic implants, it also includes all of the
• diagnostic tests and
• imaging equipment currently used to pinpoint disease 
• companion diagnostics, which are needed to fulfill the promise of personalized medicine (1).

FDA 510 (k) Pending for the Latest Cardiovascular Imaging Technology

Editor’s choice of the most innovative technology at RSNA 2012

By:

Dave Fornell

December 11, 2012

Toshiba is developing a radiation dose alert to show interventionalists how much dose they have delivered to their patient from X-ray angiography.

 The latest advances in cardiovascular imaging are usually shown first at the Radiological Society of North America (RSNA) annual meeting, the largest radiology show in the world, held the last week of November in Chicago. After spending five days walking three expo halls filled with more than 600 product vendors, the following is my editor’s choice for the most innovative new cardiovascular imaging technology.

New Angiography Systems

Siemens unveiled two new 510(k)-pending angiography systems, the Artis Q and Artis Q.zen, which incorporate new X-ray tube, detector and imaging software technology that can help reduce dose significantly, while offering improved image quality.

The new X-ray tube is intended to help physicians identify small vessels up to 70 percent better than conventional X-ray tube technology. The Artis Q.zen combines this innovative X-ray source with a new detector technology designed to support interventional imaging in ultra low-dose ranges to patients, doctors and medical staff, particularly during more complex, longer interventions.

The second generation of Siemens’ flat emitter technology replaced the coiled filaments used in conventional X-ray tubes to emit electrons. Flat emitters are designed to enable smaller quadratic focal spots that lead to improved visibility of small vessels.

The Artis Q.zen combines the X-ray tube with a detector technology that allows detection at ultra-low radiation levels. It can image with doses as low as half the standard levels applied in angiography. Instead of detectors based on amorphous silicon, a new crystalline silicon structure of the Artis Q.zen detector is designed to be more homogenous, allowing for more effective amplification of the signal, greatly reducing the electronic noise.

Siemens also introduced new software applications for interventional imaging. Clear Stent Live freezes an enhanced image of a stent during deployment with the balloon radio-opaque markers and uses it as an overlay on live fluoroscopy. Siemens says the main application will be for better visualization when implanting overlapping stents or stenting bifurcation lesions. It also helps suppress and stabilize heart motion on the image.

Other new 3-D applications are designed to image the smallest structures inside the head. Their high spatial resolution is crucial for imaging intracranial stents or other miniscule structures such as the cochlea in the inner ear. Moving organs such as the lungs can be imaged in 3-D in less than three seconds, reducing motion artifacts and the required amount of contrast agent.

GE Healthcare showcased its IGS (Image Guided System) 750 hybrid OR angiography system. It was displayed at RSNA 2011, but did not receive FDA clearance until earlier this year. It offers the mobility of a mobile C-arm, but the image quality and software features of a ceiling or floor mounted fixed system. It uses laser guidance for very accurate positioning. It can rove around the room on a powered caster system to enable different positioning around the table, or be parked out of the way during open surgical procedures.

Hands-Free Physician Control of Images

GestSure displayed a new, FDA-cleared system that allows interventionalists in the cath lab, or surgeons in the operating room, to pick reference images to display on the overhead screens in the room and manipulate the images all hands-free. It allows physicians to pick and enlarge the images they need for better procedural navigation, while maintaining the sterile field.

A video sensor detects all the people in the work area and displays their outlines on a separate screen, with each person assigned a specific color. When one of those people raises their arms in the “hands up” pose, the system detects this and allows the person control of the system. Using the right arm/hand, they can scroll through images and use the left arm/hand as a mouse click by a pushing motion forward. The system detects the motions and translates them in real time to mouse actions on the overhead screen.

The software works as a vendor-neutral layer on top of existing PACS or advanced visualization software.

Outpatient, Office-Based Catheter Interventions

Outpatient, office-based peripheral vascular procedures are an increasing trend, according to GE healthcare, which showcased a new “mobile hybrid OR” solution. The trend includes setting up an outpatient cath lab in an office setting to reduce the costs of using hospital ORs or cath labs. The room system GE highlighted centers around its OEC 9900 Elite mobile C-arm and Venue 40, which is combined with a ultrasound system in an all-in-one unit. The GE Venue 40 tablet ultrasound system is mounted within the OEC 9900 Elite C-arm’s workstation to reduce the floor space required.

Wireless Ultrasound Transducer

Siemens introduced the world’s first wireless transducer ultrasound system, the Acuson Freestyle. It eliminates the impediment of cables in ultrasound imaging by using a battery-powered transducer, about the size of a large TV controller. The transducer can be submerged for cleaning. It is capable of 90 minutes of continuous scanning before the battery needs to be recharged.

The Freestyle is a point-of-care system that will expand ultrasound’s use in interventional and therapeutic applications. The transducer can be used to image up to 10 feet from the console. Siemens said it hopes to refine and expand the wireless transducer technology to its other systems in the coming years.

Engineers had to overcome several issues to create a wireless transducer. For example, a cardiac echo requires about 40 frames per second and each frame is equal to about 1 megabyte of data. To accommodate the amount of data and speed the computer processing involved, some of the electronics are placed in the transducer rather than processing the data in the machine console. The wireless system transmits the data over an 8 GHz ultrawideband radio frequency to the console. The amount of data and the bandwidth transmitted by the transducer is equal to about 10 4G smart phones working continuously.

Noiseless MRI

GE Healthcare introduced its 510(k)-pending noiseless MRI Silent Scan technology that it hopes to introduce in 2013 for its MR450W 1.5T system. The technology addresses one of the most significant impediments to patient comfort — excessive noise generated during the exam that can be in excess of 110 decibels. A combination of software and a pulse sequence lowers the noise level to that of a chirping bird outside a window.

Historically, acoustic noise mitigation techniques have focused on insulating components and muffling sound as opposed to treating the noise at the source. With Silent Scan, acoustic noise is essentially eliminated by employing a new advanced 3-D acquisition and reconstruction technique called Silenz, in combination with GE Healthcare’s proprietary design of the high-fidelity MR gradient and RF system electronics. Silent Scan is designed to eliminate the noise at its source.

640-Slice CT Scanner

Toshiba unveiled its 640-slice Aquilion One Vision edition CT scanner. The vendor already offers the highest-slice system on the market, the 320-slice Aquilion One. The new system is equipped with a gantry rotation of 0.275 seconds, a 100 kw generator and 320 detector rows (640 unique slices) covering 16 cm in a single rotation, with the industry’s thinnest slices at 500 microns (0.5 mm). The system can accommodate larger patients with its 78 cm bore and fast rotation, including bariatric and patients with high heart rates.

FFR-Like CT Culprit Vessel Analysis

TeraRecon released new research software in response to fractional flow reserve (FFR)-CT analysis being developed by HeartFlow. The HeartFlow software uses a supercomputing algorithm to look at the fluid dynamics of the iodine contrast flow in coronary vessels to calculate a virtual a FFR number, similar to invasive pressure wire based FFR in the cath lab. TeraRecon’s Lesion Specific Analysis software cannot calculate FFR, but uses the same principle of tracking contrast flow in the myocardium. It uses lobular decomposition to look at each vessel segment to determine the tissue it feeds to show areas of ischemia and the expected culprit vessel segment. It shows a color contrast level maps on a 3-D model of the heart and in a coronal view of the left ventricle. Automated detection boxes highlight suspected ischemic areas of interest and identifies the vessel responsible for supplying blood to the region.

Radiation Dose Monitoring

Radiation dose monitoring solutions have been shown at previous RSNAs, but were highlighted by several companies this year as several states began implementing requirements for radiology departments to record patient dose. Dose records will have the most application with CT systems, especially for longer duration, higher dose cardiac exams, and catheter based angiography. Angiography is becoming an increasing issue due to the longer duration of more complex transcatheter interventions.

Toshiba demonstrated a work-in-progress dose tracking software for its Infinix-i angiography system. It can be displayed on a screen in the cath lab to show the approximate radiation dose that has been delivered cumulatively to specific areas of a patient. It takes into consideration the amount of time, power setting used and orientation of the C-arm to show a color-coded map of radiation delivery projected on a human figure. The colors change in real time as X-ray imaging continues. It is designed to be a visual reminder to physicians about the dose the patient has received and that they may want to change the location of the C-arm.

Sectra demonstrated 510(k)-pending Dose Track software, which radiology or cardiology departments can use to track radiation dose by patient, machine, physician, technologist, procedure type and room. The system can be set up to create alerts if a reasonable amount of dose if exceeded for a particular exam, or if certain physicians or technologists are using higher than average doses.

OLED Displays

Flat panel display technology migrated from CRT screens to LCDs over the past decade. The next major innovation in display technology is OLED, which offers even smaller components, faster response time than LCD, and the ability to display quick motion with virtually no blur. Sony showed the new PVM-2551MD OLED medical-grade monitor, which incorporates technology to achieve pure black, faithful to the source signal. By providing superb color reproduction, especially for dark images, surgeons can observe very subtle details such as the faint color difference between various tissues and blood vessels.

Aesthetically Pleasing Cath Labs

Philips Healthcare displayed video of its recent install of the Ambient Experience in a cath lab. The system uses colored lighting, subtle room design details and projected image visual effects to calm patients and make procedure rooms look less clinical. The installation highlighted allowed doctors or patients to choose a theme, such as a tropical rainforest, where diffused, indirect lighting would take a green hue and a photo projection on the ceiling of a tropical scene. Philips said at facilities that have installed these type of labs, patient satisfaction rose, as did staff morale. They say doctors and staff compete to use these rooms at some facilities.

Single Detector Spectral CT Imaging

Philips introduced an innovative work-in-progress CT system that uses new detector technology to simplify spectral imaging, offering soft tissue image quality similar to MRI. Currently, CT special imaging can be performed using systems with two X-ray tubes and two detectors. The new system in development uses a single X-ray source and a single detector that has two layers of detectors, one on top of the other, for high and low energy.

Better Transcatheter Mitral Valve Repair Guidance

Philips’ showed its new Echo Navigator system, designed to synchronize views from TEE ultrasound with the orientation on live angiography. The primary application is to aid navigation during transcatheter mitral valve procedures, which require very accurate 3-D echo navigation to deploy devices like the Abbott MitraClip.

3-D Sculptures From 3-D Datasets

Taking 3-D images shown on 2-D display screens to a true physical 3-D form, Vidar Systems/3D Systems displayed the new Z Printer 450. It takes any 3-D advanced visualization dataset and can print the image in true 3-D using gypsum powder (the same material used to make drywall), standard color ink jet printer cartridges and a binding agent. The image is saved as an STL file and sent to the printer, which prints 1/10^th of a millimeter each pass, up to 2 cm per hour.

The 3-D sculptures it created can be printed in color, eliminating the need to paint the models.

The printer offers a new way to create 3-D anatomical models for medical education, complex surgical planning and cosmetic reconstruction. Another application suggested at RSNA was to print sculptures for sale to the patients, such as fetal faces taken from 3-D obstetrics ultrasound exams.

The company printed a full-sized, 3-D, color heart during the show using a cardiac CT dataset on a thumb drive provided by one of the advanced visualization vendors in the same hall.

• 
  Siemens unveiled the world’s first wireless ultrasound transducer at RSNA 2012.

http://www.dicardiology.com/article/latest-cardiovascular-imaging-technology

REFERENCES

1. S. Desmond-Hellmann, Toward precision medicine: A new

social contract? Sci. Transl. Med. 4, ed3 (2012).

2. J. S. Altshuler, E. Balogh, A. D. Barker, S. L. Eck, S. H. Friend,

G. S. Ginsburg, R. S. Herbst, S. J. Nass, C. M. Streeter, J. A.

Wagner, Opening up to precompetitive collaboration. Sci.

Transl. Med. 2, 52cm26 (2010).

3. U.S. commerce department study; www.ita.doc.gov/td/

health/Medical%20Device%20Industry%20Assessment%

20FINAL%20II%203-24-10.pdf.

4. Regulatory science in FDA’s Center for Devices and

Radiological Health: A vital framework for protecting

and promoting public health; www.fda.gov/AboutFDA/

CentersOffices/OfficeofMedicalProductsandTobacco/

CDRH/CDRHReports/ucm274152.htm#.

5. Driving Biomedical Innovation: Initiatives for Improving

Products for Patients; www.fda.gov/AboutFDA/

ReportsManualsForms/Reports/ucm274333.htm.

6. G. D. Prestwich, S. Bhatia, C. K. Breuer, S. L. Dahl, C. Mason,

R. McFarland, D. J. McQuillan, J. Sackner-Bernstein, J. Schox,

W. E. Tente, A. Trounson, What is the greatest regulatory

challenge in the translation of biomaterials to the clinic?

Sci. Transl. Med. 4, 60cm14 (2012).

7. Between Invention and Innovation. NIST GRC 02-841;

www.atp.nist.gov/eao/gcr02-841/contents.htm.

8. Justin D Pearlman, MD, ME, PhD, FACC, MA; Chief Editor: Eugene C Lin, MD

Imaging in Coronary Artery Disease, Nov 13, 2012

http://emedicine.medscape.com/article/349040-overview

9. Markus Schwaiger, MD; Sibylle Ziegler, PhD; and Stephan G. Nekolla, PhD

PET/CT: Challenge for Nuclear Cardiology

THE JOURNAL OF NUCLEAR MEDICINE • Vol. 46 • No. 10 • October 2005

 

Other articles related to this topic Published on this Open Access Online Scientific Journal include the following:

New Definition of MI Unveiled, Fractional Flow Reserve (FFR) CT for Tagging Ischemia

http://pharmaceuticalintelligence.com/2012/08/27/new-definition-of-mi-unveiled-fractional-flow-reserve-ffrct-for-tagging-ischemia/

FDA: Strengthening Our National System for Medical Device Post-market Surveillance

http://pharmaceuticalintelligence.com/2012/09/07/fda-strengthening-our-national-system-for-medical-device-post-market-surveillance/

Gaps, Tensions, and Conflicts in the FDA Approval Process: Implications for Clinical Practice

http://pharmaceuticalintelligence.com/2012/07/31/gaps-tensions-and-conflicts-in-the-fda-approval-process-implications-for-clinical-practice/

To Stent or Not? A Critical Decision

http://pharmaceuticalintelligence.com/2012/10/23/to-stent-or-not-a-critical-decision/

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Cardiac Surgery Theatre in China vs. in the US: Cardiac Repair Procedures, Medical Devices in Use, Technology in Hospitals, Surgeons’ Training and Cardiac Disease Severity”

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Bio Instrumentation in Experimental Life Sciences Research, Frontiers in Cardiology and Cardiovascular Disorders, Genomic Testing: Methodology for Diagnosis, HTN, Interviews with Scientific Leaders, Medical Devices R&D and Inventions, Medical Devices R&D Investment, Mitral Valve: Repair and Replacement, Pharmacotherapy of Cardiovascular Disease, Resident-cell-based, Scientist: Career considerations, Stents & Tools, Valves & Tools, tagged Cardiac surgery, Cardiac Surgery Theatre, Heart disease, St. Jude Medical on January 8, 2013| 7 Comments »

Cardiac Surgery Theatre in China vs. in the US: Cardiac Repair Procedures, Medical Devices in Use, Technology in Hospitals, Surgeons’ Training and Cardiac Disease Severity”

 Interviewer: Aviva Lev-Ari, PhD, RN

Article ID #11: Cardiac Surgery Theatre in China vs. in the US: Cardiac Repair Procedures, Medical Devices in Use, Technology in Hospitals, Surgeons’ Training and Cardiac Disease Severity”. Published on 1/8/2013

WordCloud Image Produced by Adam Tubman

 

First segment: Interview with Dr. LCR, Cardiac Surgeon,

Interviews with Scientific Leaders Series

This is the first segment on this subject, in the Interviews with Scientific Leaders Series on our Open Access Online Scientific Journal.

This Segment and the following to be published in this Open Access Online Scientific Journal, are based on an e-mail exchange with a prominent Cardiac Surgeon who worked in the US and in China in Cardiac Surgery Theatres. The identity of the surgeon, I shall conceal. The opening segment provides background, the volume of procedures and the general overview of the medical devices in use.

Following segments will be based on an exchange of Question and Answers (Q&A) which I will be presenting to our Surgeon interviewee and his answers to these specific questions.

I plan to cover the following topics:

• Cardiac Repair Procedures
• Medical Devices in Use
• Technology in Hospitals
• Surgeons’ Training and
• Cardiac Disease Severity

Background

Dr. LCR, M.D., F.R.C.S.(C), F.A.C.S., Cardiothoracic & Vascular Surgery is the Cardiac Surgeon in this Interview with Scientific Leaders.

Dr. LCR was born in Hong Kong, SAR, China and came to the US in 1972 for higher education and became a US citizen since 1979.  He is a US medical school graduate, trained general surgeon (ABS re-certified till 12/2014) and Canadian trained cardiothoracic surgeon (ABTS re-certified till 12/2021). Dr. LCR is also a Fellow of The American College of Surgeons (F.A.C.S.) and an active member of The Society of Thoracic Surgeons (STS) since 1996. He practiced cardiothoracic and vascular surgery in the US between 1992 and 2007 when he accepted the invitation of the Foreign Experts Bureau of the Chinese government to teach/work cardiovascular surgery in China and has just returned to the US two month ago.

During those five and a half years in China, Dr. LCR worked at some of the top and largest cardiovascular programs (West China Hospital of Sichuan University at the city of Chengdu, 1,700 cardiac cases/year.

Dr. LCR worked in Guangdong Provincial Cardiovascular Institute at the city of Guangzhou, the third or fourth largest cardiac program in China, with 3,792 cardiac cases in 2011).

Dr. LCR has also authored or co-authored at least 6 scientific articles when he was in China, all published in the US cardiac journals.

Dr. LCR speaks two Chinese dialects fluently and read and write Chinese at an advanced level.

Below, we present the personal observation and opinions regarding “How the Operating Rooms (OR) are equipped and run in China and the US.”

Dr. LCR was professor of thoracic surgery at West China Hospital of Sichuan University from 06/2007 to 04/2008), the largest hospital in China, with 4,200 beds on one campus (there are three other campuses).

The hospital has 80 some OR’s and the out-patient department saw 2.5 million out-patients the year he was there.  The department of Cardiac Surgery performed 1,700 cardiac surgical cases in 2007, with 4 OR’s.

All the major US cardiac surgery vendors were represented, prosthetic heart valves, sutures,etc.. For some “Reason” we only used St. Jude Medical‘s mechanical valves, and we must have put in more than 1,200 to 1,400 valves. They were sold to the Chinese patients the same price as they were sold in the US, about US$ 3,000 each (or 21,00 CNY), about 3.6 million USD of biz for St. Jude, just from a division of the hospital.

The top two heart surgery centers are located in Beijing. Fuwei hospital did 9,700 heart surgery, and the other Aszhen hospital did close to 6,000 in 2011.

The last hospital Dr. LCR worked for as an attending/consultant surgeon until September 2012, The Guangdong Provincial General Hospital (2,400 beds)-The Guangdong Provincial Cardiovascular Institute (480 beds) is probably the third or fourth largest heart surgery center in China, did 3,782 cardiac surgical cases in 2011, most likely exceeded 4,000 in 2012.

If you add the coronary stents put in by the cardiologists in China , the biz for the medical device vendors is immense. For every one coronary bypass we did, the cardiologists must have inserted 20 or more stents. Without a doubt — China is and will be the biggest market for a lot of things, including medical devices, and you are going to the right place. Good luck.

The Next segment will present Dr. LCR’s answers to specific questions I will be e-mailing him of the following topics:

• Cardiac Repair Procedures
• Medical Devices in Use
• Technology in Hospitals
• Surgeons’ Training and
• Cardiac Disease Severity

 

 

 

 

 

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UPDATED: PLATO Trial on ACS: BRILINTA (ticagrelor) better than Plavix® (clopidogrel bisulfate): Lowering chances of having another heart attack

Posted in Aortic Valve: TAVR, TAVI vs Open Heart Surgery, Cell Biology, Signaling & Cell Circuits, Coagulation Therapy and Internal Bleeding, Disease Biology, Small Molecules in Development of Therapeutic Drugs, FDA Regulatory Affairs, Frontiers in Cardiology and Cardiovascular Disorders, Health Economics and Outcomes Research, Mitral Valve: Repair and Replacement, Origins of Cardiovascular Disease, Pharmaceutical Industry Competitive Intelligence, Pharmaceutical R&D Investment, Pharmacotherapy of Cardiovascular Disease, Regulated Clinical Trials: Design, Methods, Components and IRB related issues, tagged Adverse effect, American Heart Association, AstraZeneca, Brilinta, Clopidogrel, European Commission, European Union, Food and Drug Administration, myocardial infarction, ST elevation, Ticagrelor on December 28, 2012| 3 Comments »

UPDATED: PLATO Trial on ACS: BRILINTA (ticagrelor) better than Plavix® (clopidogrel bisulfate): Lowering chances of having another heart attack

Reporter: Aviva Lev-Ari, PhD, RN

 

UPDATED on 9/1/2019

Extended DAPT with Brilinta: No Benefit for Stable CAD in T2D

Substudy in those with prior PCI might identify group where bleeding tradeoff is worthwhile

PARIS — Ticagrelor (Brilinta) as part of a dual antiplatelet therapy (DAPT) regimen didn’t improve net outcomes for stable coronary artery disease (CAD) among type 2 diabetes patients, except perhaps in the setting of percutaneous coronary intervention (PCI), the THEMIS trial showed.

Adding the potent antiplatelet agent to aspirin reduced cardiovascular (CV) death, myocardial infarction (MI), or stroke (7.7% vs 8.5%, HR 0.90, 95% CI 0.81-0.99), reported Deepak Bhatt, MD, MPH, of Brigham and Women’s Hospital and Harvard Medical School in Boston, at the European Society of Cardiology (ESC) congress and online in the New England Journal of Medicine.

But it also increased

• TIMI major bleeding (2.2% vs 1.0%, HR 2.32, 95% CI 1.82-2.94) and
• intracranial hemorrhage (0.7% vs 0.5%, HR 1.71, 95% CI 1.18- 2.48) over aspirin alone, albeit
• without more fatal bleeding (0.2% vs 0.1%, P=0.11).

The combined effect was neutral for the exploratory composite outcome of “irreversible harm” (death from any cause, MI, stroke, fatal bleeding, or intracranial hemorrhage 10.1% vs 10.8%, HR 0.93, 95% CI 0.86-1.02).

ESC session study discussant Colin Baigent, MD, of Oxford University in England, actually calculated 12 major bleeds for every eight events prevented.

“This is a consistent story: when we add an antiplatelet agent for risk reduction, we increase the risk of bleeding,” noted Richard Kovacs, MD, of Indiana University in Indianapolis and president of the American College of Cardiology.

THEMIS is the final part of a largely-disappointing PARTHENON development program for ticagrelor, he noted. “It hasn’t changed practice. …Will the main THEMIS trial change clinical practice? In my opinion, no.”

• Primary Source

  New England Journal of Medicine

  Source Reference: Steg PG, et al “Ticagrelor in Patients with Stable Coronary Disease and Diabetes” N Engl J Med 2019; DOI: 10.1056/NEJMoa1908077.

• Secondary Source

  New England Journal of Medicine

  Source Reference: Bates ER “Antiplatelet Therapy for Prevention of Cardiovascular Events in Patients with Type-2 Diabetes Mellitus” N Engl J Med 2019; DOI: 10.1056/NEJMe1910813.

• Additional Source

  The Lancet

  Source Reference: Bhatt DL, et al “Ticagrelor in patients with diabetes and stable coronary artery disease with a history of previous percutaneous coronary intervention (THEMIS-PCI): a phase 3, placebo-controlled, randomised trial” Lancet 2019; DOI: 10.1016/S0140-6736(19)31887-2.

SOURCE

https://www.medpagetoday.com/meetingcoverage/esc/81925?xid=nl_mpt_ACC_Reporter_2019-09-01&eun=g5099207d2r

 

UPDATED on 10/4/2016

Soriot’s $3.5B Brilinta dream is dashed by yet another big trial flop for AstraZeneca

by john carroll
October 4, 2016 09:00 AM EDT
Updated: 09:33 AM

Brilinta, the drug failed to demonstrate a benefit over generic Plavix (clopidogrel) for peripheral artery disease. Back in March, the heart drug flopped in a large stroke study, unable to prove that it could beat aspirin. And Soriot can chalk up those expensive studies to proving Brilinta’s serious deficiencies.

“We don’t believe the goal of $3.5 billion is attainable. I think it would be unrealistic to believe that,” Ludovic Helfgott, head of AstraZeneca’s Brilinta business, told Reuters.

Brilinta brought in a total of $619 million last year after disappointing analysts repeatedly with lower-than-expected quarterly revenue.

Heart studies aren’t cheap. AstraZeneca recruited 13,500 patients for the EUCLID study, and it had enrolled close to that number for the earlier SOCRATES trial.

SOURCE

http://endpts.com/soriots-3-5b-brilinta-dream-is-dashed-by-yet-another-big-trial-flop-for-astrazeneca/?utm_medium=email&utm_campaign=75%20Dinner%20with%20Brent&utm_content=75%20Dinner%20with%20Brent+CID_8008d3b4f16d90576238cceef624d211&utm_source=ENDPOINTS%20emails&utm_term=Soriots%2035B%20Brilinta%20dream%20is%20dashed%20by%20yet%20another%20big%20trial%20flop%20for%20AstraZeneca

UPDATED on 9/4/2014

Prehospital Ticagrelor in ST-Segment Elevation Myocardial Infarction

Gilles Montalescot, M.D., Ph.D., Arnoud W. van ‘t Hof, M.D., Ph.D., Frédéric Lapostolle, M.D., Ph.D., Johanne Silvain, M.D., Ph.D., Jens Flensted Lassen, M.D., Ph.D., Leonardo Bolognese, M.D., Warren J. Cantor, M.D., Ángel Cequier, M.D., Ph.D., Mohamed Chettibi, M.D., Ph.D., Shaun G. Goodman, M.D., Christopher J. Hammett, M.B., Ch.B., M.D., Kurt Huber, M.D., Magnus Janzon, M.D., Ph.D., Béla Merkely, M.D., Ph.D., Robert F. Storey, M.D., D.M., Uwe Zeymer, M.D., Olivier Stibbe, M.D., Patrick Ecollan, M.D., Wim M.J.M. Heutz, M.D., Eva Swahn, M.D., Ph.D., Jean-Philippe Collet, M.D., Ph.D., Frank F. Willems, M.D., Ph.D., Caroline Baradat, M.Sc., Muriel Licour, M.Sc., Anne Tsatsaris, M.D., Eric Vicaut, M.D., Ph.D., and Christian W. Hamm, M.D., Ph.D. for the ATLANTIC Investigators

September 1, 2014DOI: 10.1056/NEJMoa1407024

BACKGROUND

The direct-acting platelet P2Y₁₂ receptor antagonist ticagrelor can reduce the incidence of major adverse cardiovascular events when administered at hospital admission to patients with ST-segment elevation myocardial infarction (STEMI). Whether prehospital administration of ticagrelor can improve coronary reperfusion and the clinical outcome is unknown.

Full Text of Background…

METHODS

We conducted an international, multicenter, randomized, double-blind study involving 1862 patients with ongoing STEMI of less than 6 hours’ duration, comparing prehospital (in the ambulance) versus in-hospital (in the catheterization laboratory) treatment with ticagrelor. The coprimary end points were the proportion of patients who did not have a 70% or greater resolution of ST-segment elevation before percutaneous coronary intervention (PCI) and the proportion of patients who did not have Thrombolysis in Myocardial Infarction flow grade 3 in the infarct-related artery at initial angiography. Secondary end points included the rates of major adverse cardiovascular events and definite stent thrombosis at 30 days.

Full Text of Methods…

RESULTS

The median time from randomization to angiography was 48 minutes, and the median time difference between the two treatment strategies was 31 minutes. The two coprimary end points did not differ significantly between the prehospital and in-hospital groups. The absence of ST-segment elevation resolution of 70% or greater after PCI (a secondary end point) was reported for 42.5% and 47.5% of the patients, respectively. The rates of major adverse cardiovascular events did not differ significantly between the two study groups. The rates of definite stent thrombosis were lower in the prehospital group than in the in-hospital group (0% vs. 0.8% in the first 24 hours; 0.2% vs. 1.2% at 30 days). Rates of major bleeding events were low and virtually identical in the two groups, regardless of the bleeding definition used.

Full Text of Results…

CONCLUSIONS

Prehospital administration of ticagrelor in patients with acute STEMI appeared to be safe but did not improve pre-PCI coronary reperfusion. (Funded by AstraZeneca; ATLANTIC ClinicalTrials.gov number, NCT01347580.)

SOURCE

http://www.nejm.org/doi/full/10.1056/NEJMoa1407024?query=TOC

 

 

UPDATED on 2/7/2014

PLATO Controversy Hits the Wall Street Journal

Michael O’Riordan

February 05, 2014

NEW YORK, NY – The controversy surrounding the PLATOtrial of ticagrelor (Brilinta, AstraZeneca) continues unabated, according to a story published in the Wall Street Journal. Specifically, a sealed complaint filed in US district court in the District of Columbia by a researcher contends that the cardiovascular events in the study “may have been manipulated” ^[1].

Dr Victor Serebruany (HeartDrug Research Laboratories, Johns Hopkins University, Towson, MD), who has long been a thorn in the side of AstraZeneca and the PLATO investigators, filed the complaint under the False Claims Act, reports theWall Street Journal. The Journal notes that the US attorney’s office in Washington, DC, has contacted Serebruany and is currently investigating the clinical trial.As reported by heartwirein October 2013, the US Department of Justice issued a civil investigative demand from its civil division “seeking documents and information regarding PLATO.” AstraZeneca is complying with the request.

First reported by heart wirein 2009 , the PLATO trial was a positive study involving more 18 000 patients from 43 countries. PLATO investigators, led by Dr Lars Wallentin (Uppsala Clinical Research Center, Sweden), showed that treating acute coronary syndrome patients with ticagrelor significantly reduced the rate of MI, stroke, and cardiovascular death compared with patients taking clopidogrel. Results were presented at the European Society of Cardiology 2009 Congress and reported in the New England Journal of Medicine.

PLATO has been dogged by questions, including prior to approval. In the sealed complaint, Serebruany takes issue with a number of things, many of which have been reported previously. He alleges that the

• number of clinical events among those taking clopidogrel was high compared with other studies, pointing out that the rate of all-cause death was 5.9% among clopidogrel-treated patients—nearly twice as high as earlier studies. In addition,
• the sealed complaint documents the geographic discrepancies in the trial, noting there was a trend toward worse outcomes with ticagrelor at North American sites.The complaint also alleges that
• an initial count of clinical events suggested the two drugs were equivalent, but adjudication by the Duke Clinical Research Institute attributed another 45 MIs to the clopidogrel group, which tipped the results in favor of ticagrelor. Other questions raised about the study include
• site monitoring and timing of clinical events. Serebruany also alleges that
• the trial may have unintentionally been unblinded because of the shape of clopidogrel’s “split capsules,” which would have enabled doctors and nurses to know which drug patients received.

AstraZeneca rebutted these issues, telling the Journal that it is cooperating with the government. It said it is confident in the integrity of the trial and noted the overall study showed the superiority of ticagrelor over clopidogrel. There is no evidence the trial was unblinded and researchers used the same standards when qualifying all clinical events, including MIs, they noted. In addition, the company said it is not possible to compare event rates with clopidogrel in PLATO with other studies because the patient populations differ.

The Journal reports that Serebruany became embroiled in the controversy when asked by the FDA‘s Dr Thomas Marciniak to advise the agency about the PLATO data in 2010. Marciniak, who led the FDA’s review of PLATO, called AstraZeneca’s submission on serious adverse events the “worst submission” he ever encountered. According to the submission, he noted, 12 patients reported their own deaths by telephone. Before approving ticagrelor, the FDA requested an additional analysis of PLATO, and it was eventually approved in the US in July 2011. Ticagrelor was approved in Europe in December 2010 and is authorized for use in more than 100 countries.

The Journal called Serebruany an expert in the antiplatelet field but said he is a “controversial figure,” partly because of his financial ties to industry and repeated criticisms of new drug approvals. Through HeartDrug Research, Serebruany has worked on prasugrel (Effient, Lily/Daiichi-Sankyo), a competing antiplatelet agent, but has also done work for AstraZeneca.

REFERENCE

Burton TM. Doctor challenges testing of AstraZeneca’s Brilinta. Wall Street Journal, February 2, 2014. Available here.

SOURCE

http://www.medscape.com/viewarticle/820236?nlid=47583_1984&src=wnl_edit_medn_card&uac=93761AJ&spon=2

UPDATED 3/28/2013

How AstraZeneca Will Use A Diagnostic To Market Its Blood Thinner

by Matthew Harper, Forbes Staff on 3/21/2013

Earlier today I wrote about how AstraZeneca is telling investors that its blood-thinner Brilinta, used to prevent second heart attacks, could be a multi-billion dollar drug, at least twice as big as Wall Street analysts expect. So far the drug has been a disappointment.

I wrote:

Another key data point Astra presented was that blood levels of troponin, a muscle protein released by the heart during a heart attack, predict which patients get the most benefit from Brilinta. This data is not in AstraZeneca’s label, but a spokeswoman said that she believed it would be something the company can market to doctors.

via Can Pascal Soriot Turn Around AstraZeneca? It May Come Down To One Drug – Forbes.

But will the Food and Drug Administration allow Astra to tell doctors that? Stratification using troponin is not in Brilinta’s FDA-approved label, and off-label promotion is illegal. But Ferguson says that communications about troponin will be allowed because all patients with high troponin are patients who would be included in the FDA-approved indication. He confirms that use of troponin testing will be part of the new marketing plan for Brilinta.

SOURCE:

http://www.forbes.com/sites/matthewherper/2013/03/21/how-astrazeneca-will-use-a-diagnostic-to-market-its-blood-thinner/

Can Pascal Soriot Turn Around AstraZeneca? It May Come Down To One Drug

by Matthew Herper, Forbes Staff on 3/21/2013

This morning in New York, new AstraZeneca chief executive Pascal Soriot is telling investors how he is going to turn around the company that has had the absolute worst track record in research and development among any big pharmaceutical firm. The plan is fairly wide-ranging and involves a lot of the steps one might expect:

• new layoffs (2,300 jobs);
• a re-focusing of research and development on three areas: heart disease and diabetes; oncology; and respiratory and inflammation;
• new R&D initiatives involving Moderna, a biotech company, and the Karolinska Instutet;
• moving the company’s headquarters to its R&D hub in Cambridge, U.K.;
• re-focusing on emerging markets, where AZ already gets $6 billion in sales, especially China.

But the short-term key to delivering on his promises today seems to come down to a single drug: Brilinta, the Plavix competitor thatAstraZeneca introduced in 2011 which has so far disappointed, generating  just $324 $89 million in global sales last year. This is a medicine to prevent heart attacks and strokes in patients who suffer acute coronary syndrome, the condition that occurs after a heart attack or serious heart-related chest pain. It works by preventing the formation of blood clots.

Plavix was the second biggest drug in the world, with $6 billion in annual sales, but it is now generic. The conventional wisdom is that it will be difficult to compete with cheap generics. Brilinta is actually trailing Effient, a similar medicine from Eli Lilly, in usage. Wall Street consensus currently sees Brilinta growing to become a moderate-sized drug in 2018, with $1.3 billion in annual sales. But AstraZeneca is saying that it thinks Brilinta can be a multi-billion dollar product. Astra has confirmed that this means Brilinta will have to surpass Effient. The newer drugs also cause more bleeding than Plavix.

What is the company’s argument? In his presentation today, Paul Hudson, Astra’s Executive Vice President, North America, said that the key would be focusing on one key fact: Brilinta reduced cardiovascular deaths by 21% compared to Plavix in a big clinical trial. That would mean that if everyone eligible for Brilinta got it, 100,000 lives would be saved.

But the reality is that doctors have been skeptical of that data because in the part of that trial that was run in North America, the benefit was less clear. AstraZeneca says that this may have been due to an interaction of Brilinta and aspirin and that, according to current cardiovascular guidelines, doctors should be prescribing less aspirin anyway.

Another key data point Astra presented was that blood levels of troponin, a muscle protein released by the heart during a heart attack, predict which patients get the most benefit from Brilinta. This data is not in AstraZeneca’s label, but a spokeswoman said that she believed it would be something the company can market to doctors.

A lot of what Astra will do in the short term on Brilinta will be blocking and tackling. It needs to pay bigger rebates to insurers to make sure that patients can get cheap access to the drug. (This is how discounts happen in the American insurance system: the patient pays a co-payment and the insurer pays full price for the drug, but then the drug maker gives the insurer money back to make the end cost cheaper.) It will also be doing a lot of medical marketing, involving its internal experts or paid, external doctors, to get the word out about the benefits of Brilinta.

Brilinta has other advantages (it stops acting quickly) and disadvantages (it must be given twice a day). But the other big question for expanding results is whether large clinical trials that are now ongoing will show that it works in a broader array of heart patients. Astra is starting a big trial to show Brilinta prevents strokes. These trials are risky and expensive, but there will be a big payoff if they work.

Astra has some other commercial levers to point to. It’s diabetes pill Onglyza, which is sold with Bristol-Myers Squibb, will have results in a big study of its efficacy in preventing heart disease before a similar study of Merck’s top-selling Januvia, which started first. Soriot has smart ideas about which drugs to advance into later testing. But Brilinta is going to be the biggest single indicator of whether Soriot’s new strategies are paying off.

SOURCE:

http://www.forbes.com/sites/matthewherper/2013/03/21/can-pascal-soriot-turn-around-astrazeneca-it-may-come-down-to-one-drug/

BRILINTA is an antiplatelet medication

Taking BRILINTA is a first step in the treatment your physician has chosen for you. At BRILINTA.com, you will find helpful information and useful learning tools to help you complete your course of BRILINTA therapy. Make sure you and your loved ones read through all of the sections.

What is BRILINTA?

BRILINTA is a type of prescription antiplatelet medication for people who have had a recent heart attack or severe chest pain that happened because their heart wasn’t getting enough oxygen and who are being treated with medicines or procedures to open blocked arteries in the heart. BRILINTA is used with aspirin to stop platelets from sticking together and forming a blood clot that could block blood flow to the heart and cause another, possibly fatal, heart attack. Platelets are small cells in the blood that help with normal blood clotting.

Take BRILINTA and aspirin exactly as instructed by your doctor: BRILINTA twice a day, plus one 81-mg aspirin tablet once a day. You should not take a dose of aspirin higher than 100 mg each day because it can affect how well BRILINTA works. Tell your doctor about any medicines you are taking that contain aspirin. Do not take any new medicines that contain aspirin.

Why BRILINTA?

BRILINTA used with aspirin lowers your chance of having another serious problem with your heart or blood vessels such as heart attack, stroke, or blood clots in your stent if you received one. These can be fatal. In fact, in a large clinical study BRILINTA was even better than Plavix^® (clopidogrel bisulfate) tablets at lowering your chances of having another heart attack.

BRILINTA is used to lower your chance of having another heart attack or dying from a heart attack, but BRILINTA (and similar drugs) can cause bleeding that can be serious and sometimes lead to death.

Taking BRILINTA

Complete the
Course Program

IMPORTANT SAFETY INFORMATION ABOUT BRILINTA

BRILINTA is used to lower your chance of having another heart attack or dying from a heart attack or stroke, but BRILINTA (and similar drugs) can cause bleeding that can be serious and sometimes lead to death. Instances of serious bleeding, such as internal bleeding, may require blood transfusions or surgery. While you take BRILINTA, you may bruise and bleed more easily and be more likely to have nosebleeds. Bleeding will also take longer than usual to stop.

Call your doctor right away if you have any signs or symptoms of bleeding while taking BRILINTA, including: severe, uncontrollable bleeding; pink, red, or brown urine; vomit that is bloody or looks like coffee grounds; red or black stool; or if you cough up blood or blood clots.

Do not stop taking BRILINTA without talking to the doctor who prescribes it for you. People who are treated with a stent, and stop taking BRILINTA too soon, have a higher risk of getting a blood clot in the stent, having a heart attack, or dying. If you stop BRILINTA because of bleeding, or for other reasons, your risk of a heart attack or stroke may increase. Tell all your doctors and dentists that you are taking BRILINTA. To decrease your risk of bleeding, your doctor may instruct you to stop taking BRILINTA 5 days before you have elective surgery. Your doctor should tell you when to start taking BRILINTA again, as soon as possible after surgery.

Take BRILINTA and aspirin exactly as instructed by your doctor. You should not take a dose of aspirin higher than 100 mg daily because it can affect how well BRILINTA works. Tell your doctor if you take other medicines that contain aspirin. Do not take new medicines that contain aspirin.

Do not take BRILINTA if you are bleeding now, especially from your stomach or intestine (ulcer), have a history of bleeding in the brain, or have severe liver problems.

BRILINTA can cause serious side effects, including bleeding and shortness of breath. Call your doctor if you have new or unexpected shortness of breath or any side effect that bothers you or that does not go away. Your doctor can decide what treatment is needed.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. BRILINTA may affect the way other medicines work, and other medicines may affect how BRILINTA works.

Approved uses
BRILINTA is a prescription medicine for people who have had a recent heart attack or severe chest pain that happened because their heart wasn’t getting enough oxygen and who are being treated with medicines or procedures to open blocked arteries in the heart.

BRILINTA is used with aspirin to lower your chance of having another serious problem with your heart or blood vessels such as heart attack, stroke, or blood clots in your stent if you received one. These can be fatal.

Please read Prescribing Information, including Boxed WARNINGS.

Please read Medication Guide.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are without prescription coverage and cannot afford your medication, AstraZeneca may be able to help. For more information, please visit www.AstraZeneca.com.

This product information is intended for US consumers only.

BRILINTA is a trademark of the AstraZeneca group of companies.

Plavix® is a registered trademark of sanofi-aventis.

©2012 AstraZeneca.706809-1789005 8/12

SOURCE:

http://www.brilinta.com/antiplatelet-prescription-medication.aspx#au

http://www1.astrazeneca-us.com/pi/brilinta.pdf

BRILINTA (ticagrelor)

Ticagrelor (trade name Brilinta in the US, Brilique and Possia in the EU) is a platelet aggregation inhibitor produced by AstraZeneca. The drug was approved for use in the European Union by the European Commission on December 3, 2010.^[1][2] The drug was approved by the US Food and Drug Administrationon July 20, 2011.^[3]

Indications

Ticagrelor is indicated for the prevention of thrombotic events (for example stroke or heart attack) in patients with acute coronary syndrome or myocardial infarction with ST elevation. The drug is combined with acetylsalicylic acid unless the latter is contraindicated.^[4] Treatment of acute coronary syndrome with ticagrelor as compared with clopidogrel significantly reduces the rate of death.^[5]

Contraindications

Contraindications for ticagrelor are: active pathological bleeding and a history of intracranial bleeding, as well as reduced liver function and combination with drugs that strongly influence activity of the liver enzymeCYP3A4, because the drug is metabolized via CYP3A4 and excreted via the liver.^[4]

Adverse effects

The most common side effects are shortness of breath (dyspnea, 14%)^[6] and various types of bleeding, such as hematoma, nosebleed, gastrointestinal, subcutaneous or dermal bleeding. Allergic skin reactions such as rash and itching have been observed in less than 1% of patients.^[4]

Physical and chemical properties

Ticagrelor is a nucleoside analogue: the cyclopentane ring is similar to the sugar ribose, and the nitrogen rich aromatic ring system resembles the nucleobase purine, giving the molecule an overall similarity toadenosine. The substance has low solubility and low permeability under the Biopharmaceutics Classification System.^[1]

Ticagrelor as a nucleoside analogue

The nucleoside adenosinefor comparison

Pharmacokinetics

Ticagrelor is absorbed quickly from the gut, the bioavailability being 36%, and reaches its peak concentration after about 1.5 hours. The main metabolite, AR-C124910XX, is formed quickly via CYP3A4 by de-hydroxyethylation at position 5 of the cyclopentane ring.^[7] It peaks after about 2.5 hours. Both ticagrelor and AR-C124910XX are bound to plasma proteins (>99.7%), and both are pharmacologically active. Blood plasma concentrations are linearly dependent on the dose up to 1260 mg (the sevenfold daily dose). The metabolite reaches 30–40% of ticagrelor’s plasma concentrations. Drug and metabolite are mainly excreted via bile and feces.

Plasma concentrations of ticagrelor are slightly increased (12–23%) in elderly patients, women, patients of Asian ethnicity, and patients with mild hepatic impairment. They are decreased in patients that described themselves as ‘coloured’ and such with severe renal impairment. These differences are considered clinically irrelevant. In Japanese people, concentrations are 40% higher than in Caucasians, or 20% after body weight correction. The drug has not been tested in patients with severe hepatic impairment.^[4]

Mechanism of action

Like the thienopyridines prasugrel, clopidogrel and ticlopidine, ticagrelor blocks adenosine diphosphate (ADP) receptors of subtype P2Y₁₂. In contrast to the other antiplatelet drugs, ticagrelor has a binding site different from ADP, making it an allosteric antagonist, and the blockage is reversible.^[8] Moreover, the drug does not need hepatic activation, which might work better for patients with genetic variants regarding the enzyme CYP2C19 (although it is not certain whether clopidogrel is significantly influenced by such variants).^[9][10][11]

Comparison with clopidogrel

The PLATO trial, funded by AstraZeneca, in mid-2009 found that ticagrelor had better mortality rates than clopidogrel (9.8% vs. 11.7%, p<0.001) in treating patients with acute coronary syndrome. Patients given ticagrelor were less likely to die from vascular causes, heart attack, or stroke but had greater chances of non-lethal bleeding (16.1% vs. 14.6%, p=0.0084), higher rate of major bleeding not related to coronary-artery bypass grafting (4.5% vs. 3.8%, P=0.03), including more instances of fatal intracranial bleeding. Rates of major bleeding were not different. Discontinuation of the study drug due to adverse events occurred more frequently with ticagrelor than with clopidogrel (in 7.4% of patients vs. 6.0%, P<0.001)^[5] The PLATO trial showed a statistically insignificant trend toward worse outcomes with ticagrelor versus clopidogrel among US patients in the study – who comprised 1800 of the total 18,624 patients. The HR actually reversed for the composite end point cardiovascular (death, MI, or stroke): 12.6% for patients given ticagrelor and 10.1% for patients given clopidogrel (HR = 1.27). Some believe the results could be due to differences in aspirin maintenance doses, which are higher in the United States.^[12] Others state that the central adjudicating committees found an extra 45 MIs in the clopidogrel (comparator) arm but none in the ticagrelor arm, which improved the MI outcomes with ticagrelor. Without this adjudication the trials’ primary efficacy outcomes should not be significant^[13]

Consistently with its reversible mode of action, ticagrelor is known to act faster and shorter than clopidogrel.^[14] This means it has to be taken twice instead of once a day which is a disadvantage in respect of compliance, but its effects are more quickly reversible which can be useful before surgery or if side effects occur.^[4][15]

Interactions

Inhibitors of the liver enzyme CYP3A4, such as ketoconazole and possibly grapefruit juice, increase blood plasma levels and consequently can lead to bleeding and other adverse effects. Conversely, drugs that are metabolized by CYP3A4, for example simvastatin, show increased plasma levels and more side effects if combined with ticagrelor. CYP3A4 inductors, for example rifampicin and possibly St. John’s wort, can reduce the effectiveness of ticagrelor. There is no evidence for interactions via CYP2C9.

The drug also inhibits P-glycoprotein (P-gp), leading to increased plasma levels of digoxin, ciclosporin and other P-gp substrates. Ticagrelor and AR-C124910XX levels are not significantly influenced by P-gp inhibitors.^[4]

In the US a boxed warning states that use of ticagrelor with aspirin doses exceeding 100 mg/day decreases the effectiveness of the medication.^[16]

References

1. ^ ^a b “Assessment Report for Brilique”. European Medicines Agency. January 2011.
2. ^ European Public Assessment Report Possia
3. ^ “FDA approves blood-thinning drug Brilinta to treat acute coronary syndromes”. FDA. 20 July 2011.
4. ^ ^{a b c d e f} Haberfeld, H, ed. (2010) (in German). Austria-Codex (2010/2011 ed.). Vienna: Österreichischer Apothekerverlag.
5. ^ ^a b Wallentin, Lars; Becker, RC; Budaj, A; Cannon, CP; Emanuelsson, H; Held, C; Horrow, J; Husted, S et al. (August 30, 2009). “Ticagrelor versus Clopidogrel in Patients with Acute Coronary Syndromes”. NEJM 361 (11): 1045–57. doi:10.1056/NEJMoa0904327. PMID 19717846.
6. ^ Brilinta: Highlights of prescribing information
7. ^ Teng, R; Oliver, S; Hayes, MA; Butler, K (2010). “Absorption, distribution, metabolism, and excretion of ticagrelor in healthy subjects”. Drug metabolism and disposition: the biological fate of chemicals 38 (9): 1514–21. doi:10.1124/dmd.110.032250. PMID 20551239.
8. ^ Birkeland, Kade; Parra, David; Rosenstein, Robert (2010). “Antiplatelet therapy in acute coronary syndromes: focus on ticagrelor”. Journal of Blood Medicine 1: 197–219.
9. ^ H. Spreitzer (February 4, 2008). “Neue Wirkstoffe – AZD6140” (in German). Österreichische Apothekerzeitung (3/2008): 135.
10. ^ Owen, RT, Serradell, N, Bolos, J (2007). “AZD6140”. Drugs of the Future 32 (10): 845–853. doi:10.1358/dof.2007.032.10.1133832.
11. ^ Tantry, Udaya S; Bliden, Kevin P (2010). “First Analysis of the Relation Between CYP2C19 Genotype and Pharmacodynamics in Patients Treated With Ticagrelor Versus Clopidogrel”. Circulation: Cardiovascular Genetics 3: 556–566. doi:10.1161/CIRCGENETICS.110.958561.
12. ^ Bernardo Lombo, José G Díez. Ticagrelor: the evidence for its clinical potential as an oral antiplatelet treatment for the reduction of major adverse cardiac events in patients with acute coronary syndromes Core Evid. 2011; 6: 31–42. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3065559/
13. ^ Serebruany VL, Atar D. Viewpoint: Central adjudication of myocardial infarction in outcome-driven clinical trials—Common patterns in TRITON, RECORD, and PLATO? Thromb Haemost 2012; DOI: 10.1160/TH12-04-0251. http://www.theheart.org/article/1433145/print.do
14. ^ Miller, R (24 February 2010). “Is there too much excitement for ticagrelor?”. TheHeart.org.
15. ^ H. Spreitzer (17 January 2011). “Neue Wirkstoffe – Elinogrel” (in German). Österreichische Apothekerzeitung (2/2011): 10.
16. ^ July 20, 2011 AstraZeneca: Ticagrelor (Brilinta) Gains FDA Approval Larry Husten cardiobrief.org/2011/07/20/astrazeneca-ticagrelor-brilinta-gains-fda-approval/

SOURCE:

http://en.wikipedia.org/wiki/Ticagrelor

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