Medtronic Wins FDA Approval for CoreValve Earlier Than Expected

FDA has approved Medtronic’s CoreValve Transcatheter aortic valve replacement product a bit earlier than expected.

Medtronic has had two pieces of news regarding its CoreValve transcatheter aortic valve replacement system in the last 24 hours so, one not so good, and the other pleasantly surprising.

The Minnesota medical technology company announced Thursday that a U.S. federal court ruled that the company haswilfully infringed on Edwards Lifesciences’ patent for transcatheter heart valve treatment and would have to pay more than $390 million in damages to the California company.

The news Friday was markedly different.

Medtronic announced that it has received the widely-anticipated FDA approval of CoreValve. Although widely anticipated, per the company’s own guidance, analysts were expecting an approval in April. In the end, the FDA approved it three months sooner, without an independent advisory panel review of CoreValve.

The product is approved for patients who are too sick to undergo invasive, open-heart surgery. A separate review of the so-called high risk patients will be undertaken by the FDA.

Clinical results have shown that a majority of aortic stenosis patients who were implanted with CoreValve TAVR system were alive at one year following the procedure. The rate of stroke at one year was also low – at 4.1%.

“The low rates of stroke and valve leakage with the CoreValve System – two of the most concerning complications of valve replacement because they increase the risk of death and have a dramatic impact on quality of life – set a new standard for transcatheter valves,” said Jeffrey J. Popma, M.D., director of Interventional Cardiology at the Beth Israel Deaconess Medical Center, Boston, and co-principal investigator of the Trial, in a news release.

Now that Medtronic has approval, it will directly compete with Edwards Lifesciences’ Sapien TAVR system, which had first-mover advantage since Nov. 2011 when FDA approved it.

But Glenn Novarro, senior analyst with RBC Capital Markets, said that the tables will turn at least for the next few months. That’s because Medtronic now will deliver the heart valves using the smallest delivery system. Edwards is hoping to introduce the Sapien XT, which has an even smaller profile in a few months, which means Medtronic has an edge for now.

Meanwhile, in a statement Friday, Edwards implied that it is more than ready to adjust to a new market competitor.

We have known that Medtronic has been pursuing approval in the U.S. for many year and have assumed that others would eventually come, as well. We received FDA approval of the Sapien valve for inoperable patients in November 2011, and an expanded indication in October 2012 to treat high-risk patients. At our investor conference, we discussed that we have modeled a U.S. competitor with a device to treat inoperable patients very early in 2014. We look forward to the approval of our next-generation Edwards Sapien XT valve, and are very pleased with the progress we shared this week on the U.S. clinical trials of our SAPIEN 3 valve, so that we can help even more patients with severe aortic stenosis.

[Photo Credit: Medtronic]

http://www.mddionline.com/article/medtronic-wins-fda-approval-corevalve-earlier-expected

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