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Medtronic has appealed a ruling by a federal judge which restricts use of the company's new heart valve device to a limited number of U.S. patients.

Medtronic appeals heart-valve device ruling

By Sabriya Rice
Posted: April 15, 2014 - 7:30 pm ET

Medtronic has appealed a ruling by a federal judge which restricts use of the company's new heart valve device to a limited number of U.S. patients. Although the judge indicated that the Medtronic device is safer and has better outcomes than that of its competitor, Edwards Lifesciences, a preliminary injunction was granted as the two device manufacturers continue their ongoing patent dispute.

The CoreValve Generation 3, an artificial heart valve manufactured by Medtronic, can be used only in U.S. patients who cannot be helped by Edwards' SAPIEN and Sapien XT heart devices, ruled U.S District Court Judge Gregory Sleet of Delaware last week.

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The court, he said, is convinced that the Medtronic device is the “safer device and that patients in whom it is implemented have better outcomes with lower risk of death,” but he remained concerned about claims the device is not “colorably different” from the competitor's devices. Both are implanted through a minimally invasive procedure, rather than through more complex open-heart surgery.

Edwards won a jury verdict regarding patent infringement in 2010 and last year asked the court to bar sales of the Medtronic device in the U.S.

In this latest ruling, Medtronic attorneys were granted a request for one week to notify hospitals who ordered the devices about the ruling and to seek emergency relief from the 3rd U.S. Circuit Court in Philadelphia. The company said in a press release issued the day of the ruling that it planned to ask the circuit court to prevent the ruling from going into effect until it determined if the injunction was properly issued.

Approved in January, Medtronic's CoreValve became the second heart valve of its type approved for use in the U.S. The SAPIEN transcatheter heart valve by Edward Lifesciences was the first, approved in 2011.

“There are good attributes on both sides,” said Dr. Sandeep Nathan, co-director of the Cardiac Catheterization Laboratory at the University of Chicago Medical Center, regarding the pros and cons of the different devices. The CoreValve is self-expanding, is available in a wider range of sizes and is much more forgiving in terms of repositioning and implantation, which is what makes it attractive, Nathan explained, but he points out that use of the device has resulted in a higher rate of permanent pacemaker implants afterwards.

On the other hand, he says the Edwards SAPIEN valve is also a good “prototypic device,” but because it is balloon expandable interventional cardiologists have one chance to correctly implant the device. Once it expands it cannot be repositioned, Nathan said. His hospital currently implants the Edwards device, but has also been awaiting the rollout of the Medtronic implant.

“We'd certainly like to have it in house,” Nathan said, noting that there are sometimes patients that have been turned down for TAVR or referred to other locations due to the technical limitations of the currently available percutaneous valves.

Both device manufacturers were ordered by the Delaware judge to immediately enter into negotiations and agree on terms that would allow a sufficient number of CoreValve devices to be provided to hospitals and clinics currently trained on their use, so that physicians can make appropriate clinical judgments.

A follow-up hearing on those discussions is anticipated in May.

Follow Sabriya Rice on Twitter: @MHSRice

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