Medtronic has announced the FDA approval of its self-expanding transcatheter CoreValve system for severe aortic stenosis patients who are too ill or frail to have their aortic valves replaced through traditional open-heart surgery. The FDA granted approval of the CoreValve device without an independent device advisory panel review after reviewing the clinical outcomes in the Extreme Risk study of the CoreValve US Pivotal trial.
According to a press release, the Extreme Risk Study met its primary endpoint of death or major stroke at one year with a rate of 25.5%, which was 40.7% lower (p<0.0001) in patients treated with the CoreValve than was expected (based on a performance goal developed in partnership with the FDA). At one month, the rate of stroke was 2.4% and it remained low over time with a one-year rate of 4.1%. Additionally, 75.6% of patients were alive at one-year. Contemporary results through the Continued Access study, an extension of the US pivotal trial, demonstrated even better survival and stroke performance.
“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, director of Interventional Cardiology at the Beth Israel Deaconess Medical Center, Boston, USA, and co-principal investigator of the trial. “The CoreValve US pivotal trial was rigorously designed and applied clinical best practices. The trial results have redefined optimum transcatheter aortic valve implantation (TAVI) outcomes in the areas that matter most to physicians and their patients, and the results are especially remarkable given the complex medical conditions and extreme frailty of this population.”
In the US Pivotal trial, the CoreValve system also achieved exceptional haemodynamics, or blood flow, post-implant with results similar to the gold standard, surgical valves. Additionally, valve leakage rates were low and decreased over time as the self-expanding valve conformed to the shape of a patient’s annulus – an improvement that has not been reported in other major TAVI studies.