Strong Clinicals Behind FDA Approval of CoreValve® for High-risk Patients

Medtronic’s CoreValve® Transcatheter Aortic Valve Implant (TAVI) System was approved by the FDA for patients at extreme risk in January 2014. Now the company has gained U.S. FDA approval to indicate the device for patients with severe aortic stenosis who are at high risk for surgery, a move which significantly increases the target population for the procedure.


First approved for sale in Europe back in 2007, Medtronic says its CoreValve System has been implanted in more than 60,000 patients in more than 60 countries. No wonder the company is sounding pretty pleased with itself over this expanded U.S. approval, especially as it appears to haver been based on strong clinical evidence from its pivotal trial. Outcomes at one year with the CoreValve System in this high risk patient group, were superior to open-heart surgery, the current gold standard for aortic valve replacement. Consequently, says the company, the FDA approved it without the need for an independent device advisory panel review. The head-to-head study, comparing transcatheter aortic valve replacement with the CoreValve System to traditional surgical aortic valve replacement, met its primary endpoint with high survival at one year for patients receiving the CoreValve System (85.8 percent), which was statistically superior to patients receiving a surgical valve (80.9 percent).

Rates of stroke, one of the most concerning complications of valve replacement were low and not statistically different than rates experienced by surgery patients. The rate of MACCE (major adverse cardiovascular or cerebral events) was significantly better for CoreValve patients at one year, and overall hemodynamic (blood flow) performance was better in CoreValve patients than in surgical patients across all time points.

The FDA approved the entire CoreValve platform – including the 23mm, 26mm, 29mm and 31mm size valves – all of which are delivered through the smallest commercially available TAVR delivery system (18Fr, or approximately 1/4 inch), making it possible to treat patients with difficult or small vasculature.

So it’s all good news for Medtronic, in the wake of the deal with Edwards that sees it gain timely and unfettered access to the U.S. market, albeit at a cost, as covered on recently.

Investigator comments

“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 David H. Adams, M.D., 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. “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.”

Company comments 

“It’s rewarding that we can now offer this life-saving therapy to patients at increased risk for surgery,” said John Liddicoat, M.D., senior vice president, Medtronic, and president of the Medtronic Structural Heart Business. “There is a lot of excitement among U.S. heart teams for the CoreValve System’s high risk approval, and its unique design that leads to the clinical outcomes seen in the High Risk Trial. We will continue to safely introduce CoreValve System to these physicians, supporting heart teams through comprehensive training and education, imaging and patient evaluation programs.”

Source: Medtronic, Inc.

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