Devices & Diagnostics

FDA device approval imminent? Impressive CoreValve data allows Medtronic to skip advisory panel

Medtronic (MDT) presented such good results from its pivotal trial on the CoreValve at the Transcatheter Cardiovascular Therapy conference, the company announced the FDA will consider device approval without the company enduring an advisory panel. This almost imminent FDA device approval makes shaky ground for Edwards Lifesciences (EW), Medtronic’s legal sparring partner and the company […]

Medtronic (MDT) presented such good results from its pivotal trial on the CoreValve at the Transcatheter Cardiovascular Therapy conference, the company announced the FDA will consider device approval without the company enduring an advisory panel. This almost imminent FDA device approval makes shaky ground for Edwards Lifesciences (EW), Medtronic’s legal sparring partner and the company which now has the only comparable device — SAPIEN — on the market in the U.S. The device would be used to treat patients with aortic stenosis who are unable to undergo open-heart surgery.

After one year, the rate of death and major stroke in the trial was 25.5 percent for CoreValve-treated patients, “40.7 percent lower … than was expected with standard therapy,” according to a company statement.

According to a company statement:

The FDA has determined it will conduct separate reviews for the Trial’s Extreme Risk and High Risk studies. Upon reviewing the CoreValve Trial’s results for extreme risk patients, the FDA has determined it has sufficient information to evaluate the safety and efficacy of the Medtronic CoreValve System for this patient group without the need for an external expert panel.

As Seeking Alpha put it: “approval in the first quarter of next year now looks all but assured.”

Medtronic said it expects device approval even for the extreme risk patients by the end of 2014.

But, it’s not all roses. Because of expense, this market has been a tough one to crack, even for EW. From the  WSJ:

Adoption of the new heart valves, however, has been much slower than anticipated. Shares of Edwards Lifesciences have fallen more than 20% this year because of lower-than-expected Sapien sales in the U.S.

The problem has been that the price of the valves — as much as $33,000 — is far higher than surgical valves, and many hospitals lose money on the procedures, said Glenn Novarro, an analyst at RBC Capital Markets. In addition, both government and private insurers in the U.S. have been strict in limiting off-label use of the devices. The global market for TAVR devices will exceed $1 billion by the end of this year, said Mr. Novarro, who projects total sales reaching $3 billion by 2018, three years later than previous projections.

Both Medtronic and Edwards have CE Marks for these valves, and Boston Scientific (BSX) announced CE Mark approval for its Lotus Valve earlier this week.

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