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Medtronic Wins FDA Nod For CoreValve TAVR Device for High-Risk Patients


Posted in Cardiovascular by Arundhati Parmar on June 12, 2014

Medtronic can now treat patients who are considered to be at high risk for open heart surgery and not just those who cannot undergo that procedure with its CoreValve transcatheter aortic valves.  


Less than six months after Medtronic got FDA approval for it CoreValve Transcatheter Aortic Valve Replacement system for patients who cannot undergo open-heart surgery, the Minnesota company announced that the device has won the regulatory nod to be used on patients who are considered to be high-risk for the more invasive procedure.

An analyst with RBC Capital Markets - Glenn Novarro - was expecting approval in the third quarter, according to a research note he published Thursday. In fact the initial CoreValve approval also came in ahead of schedule.

In a news release, Medtronic touted the fact that FDA was able to approve the device without an independent device advisory panel review because of how good the data from the clinical results were in the High Risk Study of the CoreValve U.S. Pivotal Trial. Medtronic's CoreValve has turned heads in the physician community because it has been the only TAVR system to prove that it has better clinical outcomes than open heart surgery, which so far has been the gold standard in treating patients with severe aortic stenosis. The results were obtained at one year following the device being implanted in patients.

"This rigorous trial has defined a new standard for transcatheter valve performance, with superiority results that give physicians even more confidence in making TAVR treatment decisions," said Dr. David H. Adams, chair of the Department of Cardiothoracic Surgery at the Mount Sinai Hospital, New York City, national co-principal investigator of the CoreValve U. S. Pivotal Trial, in a company news release. "With this approval, we can treat more patients due to the broad range of CoreValve sizes, and we have an option compared to surgery that provides a greater chance for a longer life while minimizing the risk of stroke."

FDA has now approved different-sized TAVR devices - 23mm, 26mm, 29mm and 31mm size valves - all of which can be delivered using a 18-French sheath. 

The only other TAVR system approved in the U.S. is Edwards Lifesciences' Sapien system. Edwards Lifesciences executives have said that they expect its next-generation Sapien XT device to be approved in the U.S. by the end of the second quarter. That device can be delivered through an even smaller 16-French expandable sheath than the Sapien device or the CoreValve device. In fact in a small, European study, Sapien XT proved to work better than the competing CoreValve device from Medtronic.

But given that Sapien XT is still not approved, Novarro of RBC Capital Markets noted that it should help Medtronic take further TAVR market share away from Edwards. Over the years, the two companies have been battling it out over patent infringement related to their respective TAVR systems. Last month, Medtronic agreed to a settlement through which it will pay at least $750 million in royalties through 2022 to Edwards Lifesciences. 

The Minnesota device maker has already paid $84 million to Edwards Lifesciences as a result of a jury verdict back in 2010.

Meanwhile, Medtronic is also expecting CE Mark for its next generation TAVR system - Evolut R - early next year, according to Novarro.

[Photo Credit: iStockphoto.com user Tolimir]  

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

 


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