Transcatheter Valve Competition in the United States: Medtronic CoreValve infringes on Edwards Lifesciences Corp. Transcatheter Device Patents
Curator: Aviva Lev-Ari, PhD, RN
UPDATED on 4/22/2014
Appeals court stays ban on Medtronic’s CoreValve device
April 21, 2014 by Brad Perriello
A federal appeals court stays a ban on U.S. sales of Medtronic’s CoreValve replacement heart valve “pending further notice” in a patent infringement battle with Edwards Lifesciences and its Sapien transcatheter aortic valve implant.

A federal appeals court today put a hold on the impending ban on U.S. sales of Medtronic‘s (NYSE:MDT) CoreValve replacement heart valve “pending further notice,” as Medtronic’s patent infringement war with rival Edwards Lifesciences (NYSE:EW) and its competing Sapien valve grinds on.
Earlier this month Judge Gregory Sleet of the U.S. District Court for Delaware granted a preliminary injunction to Edwards, limiting U.S. sales of the CoreValve transcatheter aortic heart implant to patients deemed unsuitable for Edwards’ rival Sapien device.
Medtronic promptly appealed the ban, slated to begin April 23, to the U.S. Court of Appeals for the Federal Circuit, drawing a rebuke from Sleet.
But the appeals court today granted Medtronic’s bid to stay the injunction indefinitely, with 2 of the Federal Circuit’s 3 judges agreeing to hold the sales ban on CoreValve, according to court documents.
SIMILAR ENTRIES
“The district court’s injunction is stayed pending further notice by this court,” according to the documents.
But Federal Circuit Judge Pauline Newman dissented, citing a deal between Medtronic and Edwards that would have allowed limited CoreValve sales to patients deemed unsuitable to receive the Sapien device.
“I would deny the motion to stay subject to the terms of the recent agreement between Edwards and Medtronic that Medtronic may provide its devices pending this appeal,” Newman wrote.
“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,” Medtronic structural heart president Dr. John Liddicoat said in a statement.
“We have always made every effort to ensure patients receive the treatment they need and will continue to seek a durable solution that benefits physicians and their patients. We’re proud of the track record and large amount of clinical data supporting the performance of the Sapien family of valves, making them the preferred choice for doctors treating their patients around the world,” Edwards chairman & CEO Mike Mussallem said in prepared remarks.
Edwards initially filed the infringement claim in 2008 against CoreValve, then an independent entity (Medtronic acquired CoreValve in 2009). A federal jury ruled in 2010 that the CoreValve device willfully infringes Edwards’ “Andersen” patent, also known as the ‘552 patent. The U.S. Court of Appeals affirmed that decision in 2012 and the Supreme Court last year refused to hear Medtronic’s appeal. Earlier this year the FDA approved the CoreValve system for sale in the U.S.
The legal battle is also happening overseas, where the European Patent Office in October 2013 issued a preliminary, non-binding ruling that an Edwards’ patent was invalid, allowing CoreValve back on the German market after a temporary ban. The EPO last month finalized that ruling, entirely invalidating and revoking the so-called “Spenser patent” at the heart of the overseas dispute.
Edwards earlier this year won a $393 million decision after a Delaware jury ruled that CoreValve infringes on Edwards’ “Cribier” patent.
Investigational Devices: Edwards Sapien Transcatheter Aortic Valve Transapical Deployment
June 4, 2012 by 2012pharmaceutical

The Edwards SAPIEN transcatheter heart valve is an investigational device which is placed either through a transfemoral (RetroFlex 3 Transfemoral Delivery System) or transapical (Ascendra Transapical Delivery System) approach. The Edwards SAPIEN valve is being evaluated in the treatment of patients with severe calcific aortic stenosis who are considered to be high-risk for conventional open-heartvalve replacement surgery.Cohort A of the PARTNER (Placement of AoRTic traNscatheterER valves) Trial is designed for patients with severe calcific aortic stenosis who are considered to be high-risk for conventional open-chest valve replacement due to the risk surgery might pose to them. These patients may be eligible to participate in a new, investigational transcatheter valve replacement procedure that is performed without
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Investigational Devices: Edwards Sapien Transcatheter Aortic Heart Valve Replacement Transfemoral Deployment
June 10, 2012 by 2012pharmaceutical
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U.S. Jury Finds Medtronic CoreValve Infringes on Edwards’ Transcatheter Valve Patent
Dave Fornell
MORE LIKE THIS
- U.S. Appeals Court Affirms Medtronic’s Infringement of Edwards’ Transcatheter Valve Patent
- Court Says CoreValve Infringes Patent, to Pay $74 Million
- Jury Finds Valve Infringes on Edwards’ Patent
- German Appeals Court Says CoreValve Does Not Infringe Edwards’ Patent
- Transcatheter Heart Valve Injunction Initiated in Germany
SOURCE
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
UPDATED on 11/24/2013
Second Generation Transcatheter Aortic Valve Shown to Successfully Address TAVR Complications
Related articles were published on this Open Access Online Scientific Journal, including the following:
Transcatheter Aortic Valve Replacement (TAVR): Postdilatation to Reduce Paravalvular Regurgitation During TAVR with a Balloon-expandable Valve
Larry H Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN
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. 8/13/2012 Coronary Artery Disease – Medical Devices Solutions: From First-In-Man Stent Implantation, via Medical Ethical Dilemmas to Drug Eluting Stents http://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. 7/18/2012 Percutaneous Endocardial Ablation of Scar-Related Ventricular Tachycardia
Lev-Ari, A. 6/22/2012 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. 6/19/2012 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
Lev-Ari, A. 6/22/2012 Global 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
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