Medtronic CoreValve System Receives FDA Approval for Patients at High Risk for Surgery

Medtronic, Inc. (NYSE: MDT) today announced the U.S. 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 groundbreaking 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 U.S. Pivotal Trial.
Source: News from Angioplasty.Org - Category: Cardiology Source Type: news