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Medtronic announced Thursday that the FDA extended approval of its CoreValve System to include a self-expanding catheter for use in patients with severe aortic stenosis who are at high risk for surgery. The company noted that the approval is based on research that "showed clinical outcomes at one year with the CoreValve System were superior to open-heart surgery."
The FDA approved the product without the need for an independent device advisory panel review due to the positive clinical results demonstrated in the High Risk Study of the CoreValve US pivotal trial, Medtronic said. Specifically, the study demonstrated that at one year, 85.8 percent of patients receiving the CoreValve System survived, which was statistically higher than the 80.9 percent of patients undergoing a traditional surgical aortic valve replacement. The device maker further noted that stroke rates were low in both groups, with no statistical difference between the two treatment options. However, at one year, the rate of major adverse cardiovascular or cerebral events was significantly better for the CoreValve group, and overall haemodynamic performance was better in CoreValve patients than in surgical patients across all time points.
The FDA previously approved the entire CoreValve platform, which includes the 23mm, 26mm, 29mm and 31mm size valves. In 2007 the CoreValve System received the CE mark and in January, gained FDA approval for patients with severe aortic stenosis who are deemed unsuitable for aortic valve replacement through traditional open-heart surgery.
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