TCT 2015: Medtronic touts CoreValve TAVI real-world registry data

Update: Added data from study of new patient populations Medtronic (NYSE:MDT) said today it released the 1st real-world registry study of its CoreValve transcatheter aortic valve implant, reporting outcomes in-line with its clinical trials of the device. The medtech giant also released new data from 3 studies focusing on new patient populations with significant comorbidities today. Data from all of the CoreValve studies was presented at the annual Transcatheter Cardiovascular Therapeutics conference in San Franscisco. 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 su...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiac Implants Cardiovascular Catheters Clinical Trials Medtronic TCT 2015 Source Type: news