U.S. Appeals Court Postpones Injunction Against Medtronic's CoreValve System

(RTTNews) - Medical device maker Medtronic, Inc. (MDT) announced late Monday that the Federal Circuit Court of Appeals has postponed the preliminary injunction granted last week to Edwards Lifesciences Corp. (EW) that would have limited the sale of Medtronic's CoreValve system in the U.S.

"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.

The injunction was granted last week by the U.S. District Court for the District of Delaware, and would have taken effect on Wednesday. The jury also awarded Edwards $394 million in damages.

The injunction was related to a federal jury decision in 2010 that CoreValve willfully infringed Edwards' U.S. patent for the balloon expandable Sapien transcatheter aortic valve replacement or TAVR system.

The postponement was granted on Medtronic's request that claimed Edwards Lifesciences did not meet the standards needed for an injunction, particularly with respect to the impact it will have on the public interest.

Minneapolis, Minnesota-based Medtronic noted that the preliminary injunction will only take effect if the U.S. Appeals Court determines the injunction was properly issued.

Medtronic said the appeals court has agreed to an expedited appeal of the ruling, requiring the last appeal brief to be submitted by June 19.

However, Medtronic added that the Court rulings will have no impact on the sale or marketing of the CoreValve heart valve implant outside of the U.S. or the use of CoreValve in the current U.S. clinical trials.

The patent involved in this law suit is part of the Cribier family of patents and expires in December 2017. Edwards Lifesciences' Sapien is currently the only U.S. FDA approved TAVR device on the U.S. market. It was approved in November 2011 for the treatment of inoperable patients and high-risk surgical patients.

The CoreValve is expected to become the second FDA approved TAVR system, but litigation may hinder its U.S. market launch.

The CoreValve System received approval from the U.S. FDA in January for patients at extreme risk for surgical valve replacement, but is not yet approved in the U.S. for other patient groups.

The Edwards Sapien and the Medtronic CoreValve prosthesis currently are the two most widely used prostheses worldwide.

MDT closed Monday's regular trading session at $58.94, up $0.39 or 0.67% on a volume of 3.85 million shares.