CoreValve system receives FDA approval for high-risk patients

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Medtronic has announced the US Food and Drug Administration (FDA) approval of the self-expanding transcatheter CoreValve system for patients with severe aortic stenosis who are at high risk for surgery. This approval is based on research that showed clinical outcomes at one year with the CoreValve system were superior to open heart surgery, the current gold standard for aortic valve replacement.

The FDA approved the CoreValve system without the need for an independent device advisory panel review due to its exceptionally positive clinical results demonstrated in the High Risk Study of the CoreValve US pivotal trial. The head-to-head study, comparing transcatheter aortic valve implantation (TAVI) 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%), which was statistically superior to patients receiving a surgical valve (80.9%).


“This rigorous trial has defined a new standard for transcatheter valve performance, with superiority results that give physicians even more confidence in making TAVI treatment decisions,” says David H Adams, chair of the Department of Cardiothoracic Surgery at the Mount Sinai Hospital, New York City, USA, and national co-principal investigator of the CoreValve US 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 minimising the risk of stroke.”


For patients treated with the CoreValve system in the High Risk Study, rates of stroke 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 haemodynamic (blood flow) performance was better in CoreValve patients than in surgical patients across all time points. 


The CoreValve system was approved by the FDA for patients at extreme risk in January 2014. Since receiving CE mark approval in 2007, the CoreValve system has been implanted in more than 60,000 patients in more than 60 countries.