Advertisements
Feeds:
Posts
Comments

Archive for the ‘PCI’ Category


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.

SOURCE

http://uk.reuters.com/article/uk-spectranetics-m-a-philips-idUKKBN19J0MZ?em_pos=small&ref=headline&nl_art=1

Home / About Spectranetics / Overview

http://www.spectranetics.com/about/overview/

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

http://www.spectranetics.com/about/history/

Products

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.

SOURCE

http://www.spectranetics.com/solutions/coronary-intervention/

 

 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.

Products

 SOURCE

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:

Advertisements

Read Full Post »


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

SOURCE

https://pharmaceuticalintelligence.com/2017/05/03/highlights-live-day-3-world-medical-innovation-forum-cardiovascular-%E2%80%A2-may-1-3-2017-boston-ma-%E2%80%A2-united-states/

 

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)

https://pharmaceuticalintelligence.com/2014/05/19/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

https://pharmaceuticalintelligence.com/2014/01/26/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

https://pharmaceuticalintelligence.com/2014/01/26/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

https://pharmaceuticalintelligence.com/2013/06/23/comparison-of-cardiothoracic-bypass-and-percutaneous-interventional-catheterization-survivals/

 

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.

https://pharmaceuticalintelligence.com/2013/06/23/valve-in-valve-replacements-with-transapical-transcatheter-implants/

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

https://pharmaceuticalintelligence.com/2013/06/17/postdilatation-to-reduce-paravalvular-regurgitation-during-transcatheter-aortic-valve-replacement/

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)

https://pharmaceuticalintelligence.com/2013/06/17/management-of-difficult-trans-apical-transcatheter-aortic-valve-replacement-in-a-patient-with-severe-and-complex-arterial-disease/

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

https://pharmaceuticalintelligence.com/2013/06/18/a-recommended-approach-to-the-treatmnt-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

https://pharmaceuticalintelligence.com/2013/06/20/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

https://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/

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

https://pharmaceuticalintelligence.com/2012/12/31/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

https://pharmaceuticalintelligence.com/2012/09/02/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 Stentshttps://pharmaceuticalintelligence.com/2012/08/13/coronary-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

https://pharmaceuticalintelligence.com/2012/07/18/percutaneous-endocardial-ablation-of-scar-related-ventricular-tachycardia/

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

https://pharmaceuticalintelligence.com/2012/06/13/treatment-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)

https://pharmaceuticalintelligence.com/2012/06/22/competition-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

https://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/

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

https://pharmaceuticalintelligence.com/2012/06/22/global-supplier-strategy-for-market-penetration-partnership-options-niche-suppliers-vs-national-leaders-in-the-massachusetts-cardiology-vascular-surgery-tools-and-devices-market-for-car/

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

https://pharmaceuticalintelligence.com/2012/07/23/heart-remodeling-by-design-implantable-synchronized-cardiac-assist-device-abiomeds-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

 

Read Full Post »


Tommy King Memorial Cardiovascular Symposium

Saturday CEUs in Boston, May 20

St. Elizabeth’s Medical Center

Boston, MA

May 20

7:30am – 3pm

PROGRAM SCHEDULE & SESSIONS

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 »

SOURCE

From: <acvp@getresponse.com> on behalf of “Kurt, ACVP” <kurt@acp-online.org>

Reply-To: <kurt@acp-online.org>

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

To: Aviva Lev-Ari <AvivaLev-Ari@alum.berkeley.edu>

Subject: cardiovascular symposium in Boston, May 20

Read Full Post »


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

 

WATCH VIDEO:

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.”

 

SOURCE

https://www.dicardiology.com/videos/video-bioresorbable-stent-comparable-xience-two-years-concerns

Read Full Post »


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.

SOURCE

http://www.massdevice.com/edwards-lifesciences-closes-690m-valtech-cardio-buy/?utm_source=newsletter-170124&utm_medium=email&utm_campaign=newsletter-170124&spMailingID=10291384&spUserID=MTU0MTAzNDg3OTA5S0&spJobID=1081981757&spReportId=MTA4MTk4MTc1NwS2

Edwards Lifesciences closes $690m Valtech Cardio buy

JANUARY 24, 2017 BY

EDWARDS LIFESCIENCES COMPLETES ACQUISITION OF VALTECH CARDIO
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 http://www.edwards.com and follow us on Twitter @EdwardsLifesci.
SOURCE

 

Read Full Post »


Advanced Peripheral Artery Disease (PAD): Axillary Artery PCI for Insertion and Removal of Impella Device

Reporter: Aviva Lev-Ari, PhD, RN

 

 

July 15, 2016
Authors:

Rajiv Tayal, MD, MPH1,2;  Mihir Barvalia, MD, MHA1;  Zeshan Rana, MD2;  Benjamin LeSar, MD1;  Humayun Iftikhar, MD1;  Spas Kotev, MD1;  Marc Cohen, MD1;  Najam Wasty, MD1

Abstract: Traditionally, brachial and common femoral arteries have served as access sites of choice, with many operators recently converting to radial artery access for coronary angiography and percutaneous intervention due to literature suggesting reduced bleeding risk, better patient outcomes, and lower hospital-associated costs. However, radial access has limitations when percutaneous procedures requiring larger sheath sizes are performed. Six Fr sheaths are considered the limit for safe use with the radial artery given that the typical luminal diameter of the vessel is approximately 2 mm, while peripheral artery disease (PAD) may often limit use of the common femoral artery, particularly in patients with multiple co-morbid risk factors. Similarly, the brachial artery has fallen out of favor due to both thrombotic and bleeding risks, while also not safely and reliably accommodating sheaths larger than 7 Fr. Here we describe 3 cases of a new entirely percutaneous technique utilizing the axillary artery for delivery of Impella 2.5 (13.5 Fr) and CP (14 Fr) cardiac-assist devices for protected percutaneous coronary intervention in the setting of prohibitive PAD.

J INVASIVE CARDIOL 2016;28(9):374-380. 2016 July 15 (Epub ahead of print)

Key words: axillary artery, percutaneous access, high-risk PCI

 

SOURCE

http://amptheclimeeting.com/ampcentral/articles/totally-percutaneous-insertion-and-removal-impella-device-using-axillary-artery-setting

Read Full Post »


CorPath robotic system for bifurcation lesions with placement of the Absorb GT1 Bioresorbable Vascular Scaffold (BVS) (Abbott Vascular)

Reporter: Aviva Lev-Ari, PhD, RN

 

UPDATED on 4/8/2017

BVS Stent Pulled From European Market – Bioresorbable stent will still be available in a clinical registry setting

by Larry Husten, CardioBrief, April 06, 2017

Abbott Laboratories sent a letter to European physicians informing them that the Absorb Bioresorbable Vascular Scaffold (BVS) and Absorb GT1 BVS “will only be available for use in clinical registry setting at select sites/institutions.”

The company’s action comes in response to an avalanche of bad news for the controversial device. Last fall 3-year results from the ABSORB II trial uncovered a significantly higher rate of target vessel MI. More recently, 2-year results from the pivotal ABSORB III trial confirmed those findings, showing a significant increase in target lesion failure. At the same time the FDA said that it was investigating the stent.

http://www.medpagetoday.com/cardiology/cardiobrief/64391

 

 

Robotic Radial Bifurcation Bioresorbable Vascular Scaffold (BVS) PCI placement of Abbott Vascular’s Absorb GT1

A remote-controlled robotic system was designed to address some of the procedural challenges and occupational hazards associated with traditional percutaneous coronary intervention (PCI) in addition to enhancing the degree of precision and control for the interventional procedure. We report the first large-scale, multicenter study evaluating the safety and efficacy of a novel robotic system for PCI.

 

It demonstrates the capabilities of the technology including double-wire intervention, successful BVS delivery, and the ability to re-cross through a scaffold-strut for branch vessel ostium dilatation. More experience with this technology will potentially add to its utilization in more complex lesions.

Safety and Feasibility of Robotic Percutaneous Coronary Intervention PRECISE (Percutaneous Robotically-Enhanced Coronary Intervention) Study

Author + information

Abstract

Objectives The aim of this study was to evaluate the safety as well as the clinical and technical effectiveness of robotic-assisted percutaneous coronary intervention.

Background Robotic systems have been suggested to enhance the performance of cardiovascular procedures, as well as to provide protection from the occupational hazards that are associated with interventional practice.

Methods Patients with coronary artery disease and clinical indications for percutaneous intervention were enrolled. The coronary intervention was performed with the CorPath 200 robotic system, which consists of a remote interventional cockpit and a bedside disposable cassette that enables the operator to advance, retract, and rotate guidewires and catheters. The primary endpoints were clinical procedural success, defined as <30% residual stenosis at the completion of the robotic-assisted procedure without major adverse cardiovascular events within 30 days, and device technical success, defined as the successful manipulation of the intracoronary devices using the robotic system only.

Results A total of 164 patients were enrolled at 9 sites. Percutaneous coronary intervention was completed successfully without conversion to manual operation, and device technical success was achieved in 162 of 164 patients (98.8%). There were no device-related complications. Clinical procedural success was achieved in 160 of 164 patients (97.6%), whereas 4 (2.4%) had periprocedural non–Q-wave myocardial infarctions. No deaths, strokes, Q-wave myocardial infarctions, or revascularization occurred in the 30 days after the procedures. Radiation exposure for the primary operator was 95.2% lower than the levels found at the traditional table position.

Conclusions This pivotal multicenter study with a robotic-enhanced coronary intervention system demonstrated the safety and feasibility of the system. The robotic remote-control procedure met the expected technical and clinical performance, with significantly lower radiation exposure to the operator. (Evaluation of the Safety and Effectiveness of the CorPath 200 System in Percutaneous Coronary Interventions [PCI] [PRECISE]; NCT01275092)

Reference

1. Weisz G, Metzger DC, Caputo RP, et al. Safety and feasibility of robotic percutaneous coronary intervention. J Am Coll Cardiol 2013;61:1596–1600.

 

SOURCES

J Am Coll Cardiol 2013;61:1596–1600.

http://www.invasivecardiology.com/files/Corindus%20Clinical%20Case%20Update%20-%20October%202016.pdf

http://www.invasivecardiology.com/files/Corindus%20Clinical%20Case%20Update%20-%20December%202016.pdf?inter_email=Zlk4YUF5VU9UQzE5ckNwTUJnRFd0LzJnNnJXRXZSYSt3Q2t1N1ovSmZYWT0=&inter_date=UHUvalFXSTVmSEJvTTR1L1dobWxyQT09

http://2015.icimeeting.com/wp-content/uploads/2015/12/1858-Mahmud-Hall-I-mon.pdf

Read Full Post »

Older Posts »