Archive for the ‘PCI’ Category

Expanded Stroke Thrombectomy Guidelines: FDA expands treatment window for use (Up to 24 Hours Post-Stroke) of clot retrieval devices (Stryker’s Trevo Stent) in certain stroke patients

Reporter: Aviva Lev-Ari, PhD, RN


The stent retriever from Stryker was cleared for thrombectomy-eligible patients as initial therapy to reduce paralysis and other stroke disability only as an addition to tissue plasminogen activator (tPA). Previously, the device was approved only for use within 6 hours of ischemic stroke onset.


FDA Clears Trevo Stent Retriever for Up to 24 Hours Post-Stroke

FDA move follows expanded stroke thrombectomy guidelines

by Nicole Lou, Reporter, MedPage Today/

“Time is critical following the onset of stroke symptoms. Expanding the treatment window from 6 to 24 hours will significantly increase the number of stroke patients who may benefit from treatment,” said Carlos Peña, PhD, director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health, in a statement. “Healthcare providers and their patients now have better tools for treating stroke and potentially preventing long-term disability.”

The American Heart Association and American Stroke Association recently revised their guidelines to recommend stent retriever use up to 24 hours after symptom onset. This was announced at the International Stroke Conference in January, where the DEFUSE 3 trial added to the evidence from DAWN in demonstrating benefits to relatively late endovascular thrombectomy.

In particular, DAWN data were used to support the FDA’s latest decision. Trial investigators had reported more functional independence when patients were randomized to Trevo thrombectomy over medical management alone.



FDA expands treatment window for use of clot retrieval devices in certain stroke patients

For Immediate Release

February 15, 2018


FDA expands treatment window for use of clot retrieval devices in certain stroke patients


The U.S. Food and Drug Administration today cleared the use of the Trevo clot retrieval device to treat certain stroke patients up to 24 hours after symptom onset, expanding the device’s indication to a broader group of patients. This device is cleared for use as an initial therapy for strokes due to blood clots (also known as an acute ischemic stroke) to reduce paralysis, speech difficulties and other stroke disabilities and only as an addition to treatment with a medication that dissolves blood blots called tissue plasminogen activator (t-PA). The device was previously cleared for use in patients six hours after symptom onset.

“Time is critical following the onset of stroke symptoms. Expanding the treatment window from 6 to 24 hours will significantly increase the number of stroke patients who may benefit from treatment,” said Carlos Peña, Ph.D., director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health. “Health care providers and their patients now have better tools for treating stroke and potentially preventing long-term disability.”

A stroke is a serious medical condition that requires emergency care and can cause lasting brain damage, long-term disability or even death. According to the Centers for Disease Control and Prevention, stroke is the fifth leading cause of death in the U.S. and is a major cause of serious disability for adults. About 795,000 people in the U.S. have a stroke each year. Ischemic strokes represent about 87 percent of all strokes.

The Trevo device was first cleared by the FDA in 2012 to remove a blood clot and restore blood flow in stroke patients who could not receive t-PA or for those patients who did not respond to t-PA therapy. In 2016, the FDA allowed expanded marketing of the device for certain patients in addition to treatment with t-PA if used within six hours of the onset of symptoms. Today’s expanded indication increases the amount of time that the device can be used once the symptoms are present.

Trevo is a clot removal device that is inserted through a catheter up into the blood vessel to the site of the blood clot. When the shaped section at the end of the device is fully expanded (up to three to six millimeters in diameter), it grips the clot, allowing the physician to retrieve the clot by pulling it back through the blood vessel along with the device for removal through a catheter or sheath.

The FDA evaluated data from a clinical trial comparing 107 patients treated with the Trevo device and medical management to 99 patients who had only medical management. About 48 percent of patients treated with the Trevo device were functionally independent (ranging from no symptoms to slight disability) three months after their stroke compared to 13 percent of patients who were not treated with the Trevo device.

Risks associated with using the Trevo device include a failure to retrieve the blood clot, embolization (blockage) to new territories in the brain, arterial dissections and vascular perforations, and access site complications at the femoral (thigh) artery entry point.

Trevo was reviewed through the premarket notification (510(k)) pathway. A 510(k) is a premarket submission made by device manufacturers to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. The FDA granted premarket clearance of the Trevo device to Concentric Medical Inc.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.



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FDA Approval marks first presentation of bivalirudin in frozen, premixed, ready-to-use formulation

Reporter: Aviva Lev-Ari, PhD, RN


Baxter Announces FDA Approval of Ready-to-Use Cardiovascular Medication Bivalirudin

Approval marks first presentation of bivalirudin in frozen, premixed, ready-to-use formulation

Dosing and Uses


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Spectranetics, a Technology Leader in Medical Devices for Coronary Intervention, Peripheral Intervention, Lead Management to be acquired by Philips for 1.9 Billion Euros

Reporter and Curator: Aviva Lev-Ari, PhD, RN



Philips to buy medical device maker Spectranetics for 1.9 billion euros

By Toby Sterling | AMSTERDAM

Dutch healthcare company Philips (PHG.AS) has agreed to buy U.S.-based Spectranetics Corp (SPNC.O), a maker of devices to treat heart disease, for 1.9 billion euros (£1.68 billion) including debt, as it expands its image-guided therapy business.

Spectranetics uses techniques including lasers and tiny drug-covered balloons to clean the insides of veins and arteries that have become clogged due to heart disease.

Philips will pay Spectranetics shareholders $38.50 per share, a 27 percent premium to their closing price on June 27.

Philips Chief Executive Frans van Houten has transformed the former conglomerate into a focused maker of healthcare equipment over the past five years, spinning off its lighting division (LIGHT.AS) and selling most of its remaining consumer products business.

Philips said Spectranetics, which expects sales of around $300 million this year, will continue to grow revenues at double-digit rates and will begin adding to Philips’ earnings in 2018.


Home / About Spectranetics / Overview

Spectranetics’ History – 30 years of Innovations and M&A


Coronary Intervention

Coronary Artery Disease (CAD) is the leading cause of death among men and women. Each year, one in four deaths are attributed to CAD in the United States, accounting for over a half million lives lost. From scoring balloon technology to laser atherectomy to thrombus aspiration and removal, Spectranetics offers a comprehensive portfolio of solutions to cross, prep and treat compromised vessels. Learn more about CAD by navigating through the tile grid below and exploring the products that are saving lives.



 Peripheral Intervention

Spectranetics is dedicated to helping physicians cross, prep and treat complex clinical challenges of Peripheral Artery Disease, such as Critical Limb Ischemia, Chronic Total Occlusions and In-Stent Restenosis. We provide expert tools, training, ongoing support and patient education so that you can help eradicate restenosis, and amputation and modify all plaque. Explore the tile grid below to learn more about Peripheral Artery Disease and Spectranetics’ comprehensive portfolio of products to successfully treat this challenging cardiovascular condition at every stage.



Lead Management

Managing cardiac implantable electronic device (CIED) leads has never been more important. Patients with CIEDs are on a lifelong journey, and Spectranetics is there to make sure it’s a healthy one. Making the right decision at the right time, for every patient, is critical. Lives depend on it. Explore the tile grid below to learn more about Lead Management and the products that ensure lead extraction is done safely, responsibly and predictably.

Other related articles published in this Open Access Online Scientific Journal include the following:

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Less is More: Minimalist Mitral Valve Repair: Expert Opinion of Prem S. Shekar, MD, Chief, Division of Cardiac Surgery, BWH – #7, 2017 Disruptive Dozen at #WMIF17

Reporter: Aviva Lev-Ari, PhD, RN


Highlights LIVE Day 3: World Medical Innovation Forum – CARDIOVASCULAR • MAY 1-3, 2017  BOSTON, MA • UNITED STATES

11:45 am – 12:45 pm
Boston Scientific Ballroom
Disruptive Dozen: 12 Technologies that will reinvent Cardiovascular Care
  • Chief of Cardiovascular Medicine, Brigham and Women’s Hospital
  • Associate Professor of Medicine, Harvard Medical School
  • Chief, Cardiology Division, Massachusetts General Hospital
  • Professor of Medicine, Harvard Medical School

12. Aging and Heart Disease: Can we reverse the process?

11.Nanotechnologies for Cardiac Diagnosis and Treatment

10. Breaking the Code: Diagnosis and Therapeutic Potential of RNA

9. Expanding the Pool of Organs for Transplant

8. Finding Cancer therapies without Cardiotoxicity

7. Less is more: Minimalist Mitral Valve Repair

6. Understanding Why exercise works for Just about every thing

5. Power Play: The Future of Implantable Cardiac Devices

4. Adopting the Orphan of Heart Disease

3. Targeting Inflammation in cardiovascular Disease

2. Harnessing Big Data and Deep Learning for Clinical Decision Support

  1. Quantitative Molecular Imaging for Cardiovascular Phynotypes



Excerpts from Prem S. Shekar, MD Presentation

The success achieved with TAVR

  1. least traumatic
  2. short recovery
  3. quicker return to normal lifestyle

encouraged Medical devices Manufacturers to develop Mitral Valve Repair technologies to address the large unmet need for percutaneous treatment of patients with Mitral Valve disease:

Mild or Severe (4 Million in the US, alone).

  • Mitral Regurgitation (MR) – imperfect closure of the valve permits blood from LV to return back towards the lungs.

Causes for MR

  1. the degenerative myxomatous disease
  2. senile calcific degenerative disease causing enlargement of the LV, infection or Trauma.
  • Mitral stenosis – narrowing of the valve

Causes for Mitral Stenosis

  1. rheumatic fever
  2. senile calcific degeneration – obstruction to the forward flow of blood resulting in increased fluid pressure inside the lungs.

Symptoms of MR – managed by drugs or Surgery for correction (Open Heart surgery or MIS – both procedures require use of bypass machine, the heart been stopped for the duration of repair/replacement) for Valve Repair or Valve Replacement

  1. shortness of breath
  2. fatigue

Uncorrected Mitral Valve disease can lead to 

  1. irregular heart rhythms
  2. increased risk for stroke
  3. CHF
  4. Death

Transcatheter Mitral Valve Correction

  1. Valve replacement
  2. use of Repair devices on the Mitral leaflets
  3. implantation of neochords
  4. remodeling of the mitral annulus

Comparison of TARV with Transcatheter Mitral Valve Correction

  1. Aortic Valve vs Mitral Valve: difference in complexity and artistic nature of Mitral repair
  2. Ability to perform a Percutaneous repair on a Mitral Valve with same degree of accuracy and reproducibility as a Percutaneous repair on an Aortic Valve — will remain a challenge.
  3. development of advance imaging technologies will play a key role in achieveing success with Percutaneous repair on a Mitral Valve
  4. Percutaneous repair on a Mitral Valve need to overcome the complex structure and integrated relationship with the LV.

Leading Challenges in the Development of Percutaneous repair on a Mitral Valve Technologies

  1. Mitral is a bigger Valve than the Aortic
  2. It is more difficult to access
  3. It is Asymmetrical
  4. It lacks an anatomically well-defined annulus to which to anchor the artificial valve
  5. Its geometry changes throughout the cardiac cycle
  6. Placement of a replacement valve bears the risk of LV outflow tract obstruction

Patient Candidate Profile forPercutaneous repair on a Mitral Valve

  1. Patient with a failed Mitral Valve bioprosthesis – Severe Mitral Valve Disease
  2. Failed Mitral Valve Repairs
  3. Senile calcific degeneration
  4. Mitral Regurgitation unmanaged by medication
  5. Variable surgical risk related to co-morbidities


Other related articles on Mirtal Valve Disease covered in this Open Access Online Scientific Journal Include the following:

Search Category:

Cardiovascular Medical Devices: Cardiac Surgery, Cardiothoracic Surgical Procedures and Percutaneous Coronary Intervention (PCI) / Coronary Angioplasty – 248 articles

Mitral Valve Repair: Who is a Patient Candidate for a Non-Ablative Fully Non-Invasive Procedure? – Last Updated on 4/8/2017

Justin Pearlman, MD, PhD, FACC and Aviva Lev-Ari, PhD, RN


Lev-Ari, A. 5/19/2014. Transcatheter Mitral Valve (TMV) Procedures: Centers for Medicare & Medicaid Services (CMS) proposes to cover Transcatheter Mitral Valve Repair (TMVR)


Lev-Ari, A. 1/26/2014. Transcatheter Valve Competition in the United States: Medtronic CoreValve infringes on Edwards Lifesciences Corp. Transcatheter Device Patents


Lev-Ari, A. 1/26/2014. Developments on the Frontier of Transcatheter Aortic Valve Replacement (TAVR) Devices


Larry H. Bernstein and
Aviva Lev-Ari 6/23/2013 Survivals Comparison of Coronary Artery Bypass Graft (CABG) and Percutaneous Coronary Intervention (PCI) / Coronary Angioplasty


Larry H Bernstein and Lev-Ari, A. 6/23/2013 First case in the US: Valve-in-Valve (Aortic and Mitral) Replacements with Transapical Transcatheter Implants – The Use of Transfemoral Devices.

Larry H Bernstein and  Lev-Ari, A. 6/17/2013 Transcatheter Aortic Valve Replacement (TAVR): Postdilatation to Reduce Paravalvular Regurgitation During TAVR with a Balloon-expandable Valve

Larry H Bernstein and Lev-Ari, A. 6/17/2013 Trans-apical Transcatheter Aortic Valve Replacement in a Patient with Severe and Complex Left Main Coronary Artery Disease (LMCAD)

Larry H Bernstein and Lev-Ari, A. 6/18/2013 Ventricular Assist Device (VAD): A Recommended Approach to the Treatment of Intractable Cardiogenic Shock

Larry H Bernstein and Lev-Ari, A.6/20/2013 Phrenic Nerve Stimulation in Patients with Cheyne-Stokes Respiration and Congestive Heart Failure

Lev-Ari, A. 2/12/2013 Clinical Trials on transcatheter aortic valve replacement (TAVR) to be conducted by American College of Cardiology and the Society of Thoracic Surgeons

Lev-Ari, A. 12/31/2012 Renal Sympathetic Denervation: Updates on the State of Medicine

Lev-Ari, A. 9/2/2012 Imbalance of Autonomic Tone: The Promise of Intravascular Stimulation of Autonomics

Lev-Ari, A. 8/13/2012Coronary Artery Disease – Medical Devices Solutions: From First-In-Man Stent Implantation, via Medical Ethical Dilemmas to Drug Eluting Stents

Lev-Ari, A. 7/18/2012Percutaneous Endocardial Ablation of Scar-Related Ventricular Tachycardia

Lev-Ari, A. 6/13/2012Treatment of Refractory Hypertension via Percutaneous Renal Denervation

Lev-Ari, A. 6/22/2012Competition in the Ecosystem of Medical Devices in Cardiac and Vascular Repair: Heart Valves, Stents, Catheterization Tools and Kits for Open Heart and Minimally Invasive Surgery (MIS)

Lev-Ari, A. 6/19/2012Executive 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

Lev-Ari, A. 6/22/2012Global Supplier Strategy for Market Penetration & Partnership Options (Niche Suppliers vs. National Leaders)in the Massachusetts Cardiology & Vascular Surgery Tools and Devices Market for Cardiac Operating Rooms and Angioplasty Suites

Lev-Ari, A. 7/23/2012Heart Remodeling by Design: Implantable Synchronized Cardiac Assist Device: Abiomed’s Symphony

Lev-Ari, A. (2006b). First-In-Man Stent Implantation Clinical Trials & Medical Ethical Dilemmas. Bouve College of Health Sciences, Northeastern University, Boston, MA 02115


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Tommy King Memorial Cardiovascular Symposium

Saturday CEUs in Boston, May 20

St. Elizabeth’s Medical Center

Boston, MA

May 20

7:30am – 3pm


07:30am | Registration & Continental Breakfast

08:00am | Hemodynamics; Faisal Khan, MD, St. Elizabeth’s Medical Center

09:00am | Radiation Protection; Satish Nair, PhD, F.X. Masse Associates

10:00am | Break & Exhibits

10:15am | Structural Heart – TAVR Updates and Watchman

Joseph Carrozza, MD, St. Elizabeth’s Medical Center

11:15am | Road to the Cath Lab — Triggers for STEMI Activation 

Lawrence Garcia, MD, St. Elizabeth’s Medical Center

12:15pm | Lunch

01:00pm | HF Program including Cardiomems

Lana Tsao, MD & Jaclyn Mayer, NP, St. Elizabeth’s Medical Center

02:00pm | Cath Lab Pharmacology

Mirembe Reed, Pharm.D, St. Elizabeth’s Medical Center

Register now »


From: <> on behalf of “Kurt, ACVP” <>

Reply-To: <>

Date: Monday, April 24, 2017 at 2:26 PM

To: Aviva Lev-Ari <>

Subject: cardiovascular symposium in Boston, May 20

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ACC 2017, 3/30/2017 – Poor Outcomes for Bioresorbable Stents in Small Coronary Arteries



Bioresorbable Stent Comparable to Xience at Two Years, With Concerns


Stephen Ellis, M.D., professor of medicine and director of interventional cardiology at Cleveland Clinic, discusses the two year outcomes of the ABSORB III trial of Absorb vs. Xience. The late-breaking trial was presented at ACC 2017. Read the article on the ABSORB III results.  Watch a VIDEO with Gregg Stone, M.D., “Poor Outcomes for Bioresorbable Stents in Small Coronary Arteries.”



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Edwards Lifesciences closes $690m a buy of Valtech Cardio and most of the heart valve repair technologies it’s developing

Reporter: Aviva Lev-Ari, PhD, RN


Valtech’s  Cardioband device is designed to reshape the mitral valve using specially designed anchors, aka 

transcatheter structural heart disease technologies.

Valtech won CE Mark approval in the European Union for Cardioband in September 2015 but the device is not approved for the U.S. market.

Israel-based Valtech was the target of a previous takeover attempt by HeartWare International that was spiked early this year after a proxy war. (HeartWare itself was acquired by Medtronic (NYSE:MDT) for $1.1 billion in August.)


Deal Terms:

The deal, announced in November 2016, calls for $340 million in up-front cash and another $350 million in milestones over 10 years. It does not include Valtech Cardio’s trans-septal mitral valve replacement program; that business is slated to be spun out on its own before the buyout’s closing, expected in early 2017, but Edwards said last year that it’s due to keep an option to buy.


Edwards Lifesciences closes $690m Valtech Cardio buy

JANUARY 24, 2017 BY

IRVINE, Calif., Jan. 23, 2017 – Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced that it has closed its acquisition of Valtech Cardio Ltd., a privately held company based in Israel and developer of the Cardioband System for transcatheter repair of the mitral and tricuspid valves. Edwards announced in November that it had signed an agreement to acquire Valtech.
Under the terms of the merger agreement, Edwards paid $340 million in stock and cash for Valtech at closing, subject to typical adjustments. In addition, there is the potential for up to $350 million in pre-specified milestone-driven payments over the next 10 years. Edwards’ financial guidance provided at its Investor Conference in December incorporated the expected financial impact of the transaction in 2017.
“We look forward to the Valtech team joining Edwards. We believe their knowledge, experience and the Cardioband technology are valuable additions to Edwards,” said Michael A. Mussallem, Edwards’ chairman and CEO. “This therapy has the potential to be a breakthrough structural heart therapy to help many patients in desperate need, and we look forward to gaining valuable insights from its commercial use in Europe.”
The Cardioband System is not approved for sale in the United States. The mitral application of the Cardioband System has received CE Mark in Europe.
About Edwards Lifesciences

Edwards Lifesciences, based in Irvine, Calif., is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. For more information, visit and follow us on Twitter @EdwardsLifesci.


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