Feature | April 22, 2014

U.S. Appeals Court Postpones CoreValve Injunction

Corevalve, FDA, Edwards, TAVR, TAVI, lawsuit, injunction
April 22, 2014 – The Federal Circuit Court of Appeals granted a request from Medtronic Inc. to postpone the implementation of an injunction that would have prevented the company from selling its CoreValve System in the United States. The April 21 decision means the injunction will only take effect if the appellate court determines the injunction was properly issued.
 
In addition, last week the Court of Appeals agreed to an expedited appeal of the injunction ruling, with the last appeal brief to be submitted by June 19. Medtronic does not believe Edwards Lifesciences, which brought the motion for a preliminary injunction, has met the standards needed for an injunction, particularly with respect to the impact it will have on the public interest.
 
“We believe this ruling is good news for patients who need the CoreValve device, and our primary objective has been to work closely with physicians to ensure that their patients are able to get the therapy they need,” said John Liddicoat, M.D., senior vice president, Medtronic, and president of the Medtronic structural heart business.
 
Edwards Lifesciences  said in a statement that the 2-1 court decision does not reverse the federal jury's finding of Medtronic's willful infringement, for which all appeals have been exhausted, and does not affect the determination of additional damages.
 
Last month, data presented at the American College of Cardiology (ACC) annual meeting and simultaneously published in The New England Journal of Medicine showed that patient results with CoreValve System were superior to surgical aortic valve replacement (SAVR) at one year in patients at increased risk for surgery. This is the first time a prospective, randomized study has shown any transcatheter aortic valve to be superior to surgery.
 
The CoreValve System received approval from the U.S. Food and Drug Administration (FDA) in January for patients at extreme risk for surgical valve replacement. The CoreValve System is not yet approved in the U.S. for other patient groups. Upon reviewing the CoreValve Trial’s results for high-risk patients, the FDA determined it has sufficient information to evaluate the safety and efficacy of the Medtronic CoreValve System for this patient group without the need for an external expert panel.
 
The courts’ rulings have no impact on the sale or marketing of CoreValve outside of the United States or the use of CoreValve in the current U.S. clinical trials.
 
For more information: www.medtronic.com, www.edwards.com
 

Related Content

Mitralign, Series E funding, Trialign, MPAS
News | Heart Valve Technology| May 23, 2016
Mitralign Inc. announced it has raised $39.8 million to date in a Series E equity round of financing.
TAVR outcomes, aortic valve gradient, JACC study
News | Heart Valve Technology| May 23, 2016
Patients with a combination of left ventricular dysfunction and low aortic valve gradient have higher mortality rates...
Direct Flow Medical, TAVR device, DISCOVER trial, three-year results, EuroPCR 2016
News | Heart Valve Technology| May 20, 2016
Direct Flow Medical Inc. presented three-year results from its prospective, multicenter DISCOVER Trial at the EuroPCR...
Watchman, left atrial appendage closure, LAA occluder, LAA. LAAO, laa occluder, left atrial appendage, Watchman

The Boston Scientific Watchman device is currently the only transcatheter LAA occluder cleared for use in the United States.

Feature | Left Atrial Appendage (LAA) Occluders| May 20, 2016 | Dave Fornell
Atrial fibrillation (AF) affects nearly 6 million Americans and the condition puts them at significantly greater risk
Bioventrix, Revivent-TC System, heart failure, first-in-man procedure
News | Heart Failure| May 19, 2016
BioVentrix announced the first-in-man use of its next-generation Revivent-TC System with an endovascular catheter-based...
St. Jude Medical, EuroPCR 2016 studies, FFR, LAAO, left atrial appendage occlusion, fractional flow reserve, Amplatzer
News | Cath Lab| May 19, 2016
St. Jude Medical Inc. announced results from two cardiovascular clinical trials presented at EuroPCR 2016.
RDAVR, aortic valve replacement, Edwards Intuity, TRANSFORM Trial, AATS meeting
News | Heart Valve Technology| May 18, 2016
The TRANSFORM trial was designed to evaluate the safety and performance of an investigational rapid deployment aortic...
NeoChord, DS1000 System, FDA approval, U.S. pivotal trial
News | Heart Valve Technology| May 17, 2016
NeoChord Inc. announced it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug...
4Tech Inc., TriCinch transcatheter tricuspid valve repair device, Jean-Claude Laborde

Image courtesy of 4Tech Inc.

News | Heart Valve Technology| May 16, 2016
4Tech Inc. announced its partnership with Jean-Claude Laborde, M.D., as a research and development (R&D) and...
AATS 2016, tricuspid regurgitation, post mitral valve repair, Tirone E. David, atrial fibrillation
News | Structural Heart| May 16, 2016
At the 96th American Association for Thoracic Surgery (AATS) Annual Meeting, investigators presented the results of a...
Overlay Init