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Medtronic to Court: Many Patients Will Die Without CoreValve TAVR Device


Posted in Cardiovascular by Arundhati Parmar on April 16, 2014

Medtronic adopts a dramatic argument as it fights to prevent the imminent legal removal of its CoreValve heart valve replacement system from the U.S. market.


Medtronic has chosen to use fairly dramatic words to convince the federal appeals court in Washington, D.C., that it must grant a stay on a preliminary court injunction by which its CoreValve transcatheter aortic valve replacement system cannot legally be sold in the U.S. starting April 22.

In its filing asking for an emergency temporary stay, the Minnesota medical device maker said that “many patients will unnecessarily die” if CoreValve is taken off the market. The argument is part of answering the legal question of whether an injunction against Medtronic’s device will help or hurt the public interest.

Medtronic’s appeal has its roots in a 2008 lawsuit that California-based Edwards Lifesciences brought against Medtronic citing patent infringement. Edwards makes the Sapien transcatheter aortic valve replacement system and, until earlier this year when FDA granted approval for CoreValve, was the only company in the U.S. to have an approved, commercially available TAVR device. Both these devices are meant to replace the heart valves of patients with aortic stenosis.

Medtronic cites the issue of public health repeatedly in trying to forward its case for why CoreValve needs to remain on the market.

“A stay should be entered and this appeal expedited because, if the injunction were permitted to go into effect, treatable patients may unnecessarily die in the name of already expired patent rights.”

Medtronic is referring to the Andersen patent that Edwards has said Medtronic has infringed upon, and with which a lower court has agreed. That patent expired in 2012 but Edwards has obtained temporary extensions on it. Analyst Glenn Novarro of RBC Capital Markets expects that Edwards may get a full extension till 2015 although it desires one until 2016. A decision on the timing of when the patent will finally expire is expected in mid 2014, said an Edwards spokeswoman via email.

Why is the public interest hurt if CoreValve is taken off the market, according to Medtronic?

  • CoreValve serves more patients than Sapien does - The filing states: “It is uncontested that Edwards’ Sapien product cannot be used for patients with aortic annulus diameters larger than 25mm and that Sapien XT, which has not yet been approved by the FDA, cannot be used for patients with aortic annulus diameters larger than 27 mm. In contrast, MCS is available in more sizes than Sapien and can be used for patients with up to a 29 mm annulus.”
  • CoreValve is a clinically superior product than Sapien - Even the judge granting the preliminary injunction against Medtronic conceded that CoreValve “safer device, and that patients in whom it is implanted have better outcomes with a lower risk of death.” In fact Medtronic recently presented data at the annual meeting of the American College of Cardiology that showed that CoreValve TAVR device lowers the mortality rate when compared to traditional open-heart surgery to replace diseased heart valves.

If the appeals court judgeswere composed of physicians, Medtronic likely would have a very sympathetic ear.

In fact, in a research note issued Monday, Michael Weinstein, a medical device analyst with JPMorgan Chase, reports that physicians were very surprised to learn about the ruling barring CoreValve from being sold in the U.S.

“In nearly 20 years of covering the sector, we can’t recall such a reaction from the clinical community with cardiologists and surgeons, many of whom learned of the news from our Friday night email, expressing “shock”, “outrage”, and “a state of disbelief” just two weeks after the “landscape altering” CoreValve data at the American College of Cardiology [meeting],” the note said.

It’s not clear who will win the war in this ongoing saga between Medtronic and Edwards. But Weinstein stressed that one thing is clear:

The message here is that even if Medtronic wins on appeal and gets the court to stay Judge Sleet’s injunction, whatever sales it generates over the next two years will likely see the bulk or vast majority of the profits go to Edwards while it awaits Andersen’s expiration.

In its filing asking for a temporary stay, Medtronic states that Edwards already “stands to collect at least $191 million in damages from this case.”

Meanwhile, Edwards's CEO Mike Mussallem sent a letter to the company's customers and partners, explaining, among other things, how it has a standing offer to Medtronic that would allow CoreValve to be available to medical centers that have been already trained in the procedure. 

That might not be enough for Medtronic given that it and Wall Street had fully expected that CoreValve would take share away from Edwards, given the good clinical data that CoreValve demonstrated.

[Photo Credit: iStockphoto.com user sweetandsour]

-- By Arundhati Parmar, Senior Editor, MD+DI
arundhati.parmar@ubm.com

 


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