Medtronic touts CoreValve TAVR real-world registry data

Medtronic (NYSE:MDT) said today it released the 1st real-world registry study of its CoreValve transcatheter aortic valve replacement, reporting outcomes in-line with its clinical trials of the device. The 6,160-patient Society of Thoracic Surgeons and American College of Cardiology TVT registry study reported a 5.2% rate of all-cause mortality and 2.6% rate of stroke at 30 days. Those rates are consistent with the 6.9% and 5% rates, respectively, from the pivotal trial, Fridley, Minn.-based Medtronic said. “It is reassuring to see that the profound clinical results in the U.S. CoreValve Pivotal studies were replicated among patients at high or extreme surgical risk in a ‘real-world’ clinical setting. The favorable results from the CoreValve analyses are likely attributable to operator experience, thoughtful patient selection, and effective education and training based on the ‘best practices’ learned in the U.S. pivotal studies, including the use of CT-based sizing. We believe that these results indicate that the CoreValve self-expanding bioprosthesis is safe and effective in patients with severe aortic stenosis unsuitable for surgery across a wide spectrum of U.S. medical centers,” co-principal investigator Dr. Jeffrey Popma of Boston’s Beth Israel Deaconess Medical Center said in prepared remarks. The registry study reported that implantation was sucessful in 98% of cases, with only 0.7% requiring conversion to surgery. The pivotal...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiac Implants Cardiovascular Catheters Clinical Trials Medtronic Source Type: news