The Federal Circuit Court of Appeals delayed an injunction against Medtronic's ($MDT) CoreValve transcatheter aortic valve replacement sought by Edwards Lifesciences ($EW).
The injunction, previously scheduled to take effect April 23, will now only occur if the court rules that it was properly granted, according to Medtronic.
An April 14 ruling to limit the sale of CoreValve was controversial because it limited access to a lifesaving device for some patients with severe aortic stenosis who are too frail for open-heart surgery. Patients with annulus sizes above 25 millimeters are not eligible for Edwards' competing TAVR, Sapien, and completely removing CoreValve from the market would leave them with no options.
"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 John Liddicoat said in a statement.
The rival manufacturers are negotiating an agreement to allow physicians trained in CoreValve to implant the device in certain patients without being constrained by its availability. Now, they have more time to reach such an agreement. Of course, depending on the court's final decision, it may not be necessary at all.
Last week, the court agreed to an expedited appeal of the injunction. The last appeal brief is due June 19.
The injunction does not affect any additional damages that might be ordered or overturn prior rulings that Medtronic infringed on Edwards' patents, the latter company said.
"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," Edwards CEO Michael Mussallem said in a statement.
- read the release