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

Hitachi and West Virginia University Partner to Advance Left Ventricular Mechanical Function Evaluation
News | Cardiovascular Ultrasound| July 21, 2017
Hitachi Healthcare and the West Virginia University Heart and Vascular Institute announced the formation of a new...
Sponsored Content | Videos | Cardiovascular Surgery| July 19, 2017
This video educational session, provided in partnership with the American Society of Echocardiography (ASE), is title
Edwards Sapien 3 TAVR valve will be implanted in asymptomatic aortic stenosis patients in the EARLY TAVR Trial
Feature | Heart Valve Technology| July 14, 2017
July 14, 2017 — Morristown Medical Center, part of Atlantic Health System, has randomized the first patient in the wo
Ziosoft's PhyZiodynamics 4-D processing showing a replaced aortic valve

An example of Ziosoft's PhyZiodynamics 4-D processing showing a replaced aortic valve.

Technology | Computed Tomography (CT)| July 12, 2017
July 12, 2017 — At the 2017 annual meeting for the Society of Cardiovascular Computed Tomography (SCCT), Ziosoft show
Medtronic's CoreValve Evolut R gained FDA approval for intermediate risk patients

An illustration of the self-expanding CoreValve Evolut R TAVR valve half deployed in the aortic root.

Feature | Heart Valve Technology| July 10, 2017
The U.S. Food and Drug Administration (FDA) has cleared an additional indication to expand the use Medtronic's self-...
HAART 300 Aortic Annuloplasty Device Sees U.S. Pilot Launch, First Commercial Use
News | Annuloplasty Rings| July 05, 2017
July 5, 2017 — BioStable Science & Engineering Inc.
Novel Approach May Improve Valve Function in Some Patients

Image courtesy of Messas, et al. JACC Basic to Translational Medicine.

News | Heart Valve Technology| June 30, 2017
June 30, 2017 — Pulsed cavitation ultrasound can be used to remotely soften human degenerative calcified biosprosthet
Mitralign Announces First European Subject Enrolled in SCOUT II Study of Trialign System
News | Heart Valve Technology| June 27, 2017
Mitralign Inc. announced the commencement of its SCOUT II study in Europe, with the Trialign System for the treatment...
BioTrace Medical's Tempo Lead Shows Stability and Safety in Real-World Performance
News | Leads Implantable Devices| June 20, 2017
BioTrace Medical Inc. announced that the company’s Tempo Temporary Pacing Lead was featured in an oral presentation and...
heart valve regurgitation seen on an echocardiogram, cardiac ultrasound, from ASE study
News | Cardiovascular Ultrasound| June 16, 2017
June 15, 2017 – While much attention has been focused on ways to lower heart disease-related injuries and deaths, the
Overlay Init