Does CoreValve have a pulse? A federal court of appeals granted Medtronic’s request to delay implementation of a preliminary injunction that would limit the sale of the device in the U.S.
Medtronic claimed April 21 that the court of appeals will determine if the injunction was properly issued and agreed to an expedited appeal.
Edwards Lifesciences, maker of the Sapien valve, and Medtronic, maker of CoreValve, are at legal odds over their two transcatheter aortic valve replacement (TAVR) devices. The valves are the only two products approved by the FDA as a treatment for inoperable patients with severe aortic stenosis. Edwards holds the sole FDA approval for use of a TAVR valve in high-risk patients.
Federal District Court of Delaware Chief Judge Gregory Sleet on April 11 granted the preliminary injunction. The judge allowed for a postponement of seven business days before the injunction would go into effect. On April 14, Medtronic filed an emergency motion to stay the preliminary injunction and expedite an appeal.
The patent dispute involves Edwards’ Andersen family of heart valve patents. Edwards charged in 2008 that Medtronic infringed on the patent, and in 2010 a federal jury ruled in favor of Edwards, which was upheld on appeal.
Edwards is based in Irvine, Calif.