Feature | April 16, 2014 | Dave Fornell

Federal Court Orders Injunction on U.S. Sales of Medtronic CoreValve

Medtronic plans to appeal court ruling

Corevalve beats surgery, ACC 2014, TAVR vs surgery, Edwards lawsuit
April 16, 2014 — The U.S. District Court for the District of Delaware granted a preliminary injunction limiting the sale of Medtronic's CoreValve transcatheter aortic valve replacement (TAVR) system in the United States. The court ordered the injunction April 10, which will go into effect the Week of April 21. 
 
At Medtronic's request, the Federal District Court agreed to postpone the implementation of the order for seven business days to allow Medtronic to seek prompt relief from the Federal Circuit Court of Appeals. Medtronic is appealing the court's injunction, and intends to ask the Federal Circuit Court of Appeals to prevent it from going into effect until it determines if the injunction was properly issued. 
 
The decision stems from a federal jury decision in 2010 that CoreValve willfully infringed on patent use for the Edwards Lifesciences Corp. U.S. Andersen transcatheter aortic valve replacement patent. 
 
At the conclusion of the hearing, Chief Judge Gregory Sleet ordered Edwards and Medtronic to confer on what instances the CoreValve device could continue to be used in the treatment of U.S. patients at centers currently trained on CoreValve. The companies are to agree on a mechanism that will enable physicians at facilities currently trained on CoreValve to make a clinical judgment as to which device to implant (CoreValve or the Edwards’ Sapien device) free from the limitations of the injunction. The court stated that CoreValve is a “safer device, and that patients in whom it is implanted have better outcomes with a lower risk of death.” 
 
Medtronic said the ruling has 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.
 
Edwards initiated this case in 2008. On April 1, 2010, a federal jury found Medtronic willfully infringed Edwards' U.S. Andersen patent and awarded damages. In November 2012, the U.S. Court of Appeals for the Federal Circuit affirmed the jury decision. In October 2013, the U.S. Supreme Court declined to hear Medtronic's appeal.
 
The patent involved in this suit is part of the Andersen family of patents. The U.S. Andersen patent was issued in 1995. A petition has been filed with the U.S. Patent and Trademark Office to extend this patent into early 2016. In a separate case, a federal jury in January found that Medtronic CoreValve had willfully infringed Edwards' U.S. Cribier transcatheter heart valve patent, and awarded damages to Edwards in that trial.
 
The Edwards’ Sapien TAVR system was the first to gain U.S. Food and Drug Administration (FDA) clearance in November 2011. The Medtronic CoreValve gained FDA approval this past January as the second TAVR device on the U.S. market. Many observers view the lawsuits by Edwards as a way to prevent competition in the U.S. market, similar to the suits and counter suits involved with drug-eluting stent manufactures in the United States over the past decade. Edwards filed similar suits in Europe after both valves gained market clearance there. Those suits have been ongoing for years.
 
The CoreValve System received FDA approval in January for patients at extreme risk for surgical valve replacement. Prior to that date, CoreValve therapy was available to extreme risk patients who were eligible to participate in the U.S. clinical trial. The CoreValve System is not yet approved in the U.S. for other patient groups.
 
In clinical trial data, the CoreValve appears to have better outcomes than that of the Sapien valve. At the American College of Cardiology (ACC) annual meeting in March, late-breaking trial data stated that the CoreValve actually out-performed surgical valve replacement despite the inexperience of the CoreValve operators with the device. The CoreValve U.S. pivotal high-risk patient trial showed the Medtronic self-expanding CoreValve device had a 26 percent survival benefit above the surgical valve implant patients. In the same patient population, the Edwards Sapien was found to be equal to surgery, but was not superior to surgery.
 
For more information: www.edwards.com, www.medtronic.com
 

Related Content

triple therapy, dual antiplatelet therapy, atrial fibrillation, heart attack, older patients, JACC
News | Antiplatelet and Anticoagulation Therapies| August 04, 2015
Triple therapy is no better than dual antiplatelet therapy in preventing major adverse cardiac events in older patients...
Sunshine Heart, C-Pulse, circulatory support system, update
News | Heart Failure| August 03, 2015
Sunshine Heart announced plans to commence a first-in-human study using its novel C-Pulse transcutaneous energy...
Products | Intravascular Imaging| August 03, 2015
Pie Medical Imaging, CAAS IntraVascular 2.0, OCT, IVUS, NIRS-IVUS
Technology | Intravascular Imaging| August 03, 2015
Pie Medical Imaging announced the release of CAAS IntraVascular 2.0, the dedicated software for analysis of...
European interventional cardiology market, drug-eluting stents, Abbott Laboratories, Boston Scientific, Medtronic

Boston Scientific's Eluvia drug-eluting vascular stent system. Image courtesy of Boston Scientific.

Feature | Stents| July 31, 2015
According to a new report on the Europe market for interventional cardiology by iData Research, drug-eluting stents...
Hansen Medical, Magellan 10 French Robotic Catheter, FDA 510(k) clearance
Technology | Robotic Systems| July 29, 2015
The Magellan 10 French Robotic Catheter from Hansen Medical is indicated for use in the peripheral vasculature.
Products | Guidewires| July 28, 2015
The Safari2 Pre-Shaped Guidewire.
Feature | Heart Valve Repair| July 28, 2015
Boston Scientific announced CE Mark and U.S. Food and Drug Administration (FDA) clearance for the Safari2 Pre-Shaped...
CSI, ViperWire Advance Peripheral Guide Wire with Flex Tip, Stealth, Diamondback

Diamondback 360 Peripheral OAS image courtesy of Cardiovascular Systems Inc.

Technology | Atherectomy Devices| July 22, 2015
Cardiovascular Systems Inc. announced that it has received U.S. Food and Drug Administration (FDA) clearance for its...
Direct Flow Medical, Transcatheter Aortic Valve System, SALUS Trial, FDA
News | Heart Valve Repair| July 22, 2015
Direct Flow Medical Inc. received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug...
Overlay Init