Edwards Says Medtronic’s CoreValve Should Remain Available

Apr 16, 2014 6:15 pm ET

(Updates with Medtronic comments in the eighth paragraph.)

April 16 (Bloomberg) -- Edwards Lifesciences Corp. Chief Executive Officer Michael Mussallem said the company isn’t seeking a complete ban of Medtronic Inc.’s aortic valve in the U.S., even after the company obtained an injunction against it.

Edwards, which sells the rival Sapien valve, has made multiple offers directly and through the courts that would allow patients to be treated with Medtronic’s CoreValve, Mussallem said today in a letter to doctors and other medical partners. Edwards proposed CoreValve continue to be given to people when physicians feel it is medically necessary.

An undetermined amount of compensation would be provided to Edwards for each device used, said Sarah Huoh, an Edwards spokeswoman. Medtronic has refused those offers, Mussallem said.

Medtronic rose less than 1 percent to $58.49 at the close of trading in New York, after jumping 25 percent in the past 12 months. Edwards fell less than 1 percent to $80.43 at the close, and is down 5.3 percent over 12 months.

A preliminary injunction was granted by the federal court in Wilmington, Delaware, on April 11 that would prevent Medtronic from selling its CoreValve, used to treat aortic stenosis, in the U.S. because it infringes a patent held by Irvine, California-based Edwards. The injunction was set to go into effect in seven business days.

‘Encourage’ Settlement

“In spite of the violations of our intellectual property, we are not seeking a total ban on CoreValve sales, because we understand the implications that could have for patients and physicians,” Mussallem wrote. “We encourage Medtronic to accept our standing offer to enable use of CoreValve at U.S. hospitals where it is commercially available today.”

Medtronic has asked an appeals court to let it continue selling CoreValve while it challenges the judge’s injunction decision. The order, Medtronic said in an April 14 filing, “is intolerable against the public interest in life-saving medical remedies.”

The letter from Edwards appears to respond to physicians’ concerns about restricted access to CoreValve, which has been shown to be superior to open-heart surgery to replace a damaged aortic valve, said Christopher Garland, a Medtronic spokesman.

“While it would not be appropriate to discuss the intricacies of the ongoing negotiations with Edwards in the press, Medtronic is working diligently with Edwards to reach a fair agreement so that patients’ needs may be met,” Garland wrote. “At the same time, we will not consider an agreement that will threaten our ability to appropriately service and maintain our life saving device.”