Medtronic Receives CE Mark for CoreValve System

Medtronic, Inc. MDT today announced it has received Conformité Européenne (CE) Mark for valve-in-valve (VIV) procedures using the CoreValve® and CoreValve® Evolut(TM) transcatheter aortic valve implantation (TAVI) systems in degenerated bioprosthetic surgical aortic valves. This is the first ever regulatory approval for VIV procedures, which provide a minimally invasive treatment option for patients whose surgical aortic valves have degenerated, and who are at extreme or high risk for surgery and would otherwise go untreated. The CoreValve VIV procedures are not approved in the United States. Results from the largest global VIV registry, published in Circulation in November (Transcatheter Aortic Valve Replacement for Degenerative Bioprosthetic Surgical Valves: Results from the Global Valve-in-Valve Registry), showed the VIV approach resulted in considerable hemodynamic (blood flow) improvements, including a decrease in valve gradients (blood flow resistance). Positive procedural outcomes were maintained at 1-year follow-up (with 89 percent survival at one year), which was comparable with other non-VIV TAVI studies.1 "While surgical valves provide effective therapy for many patients, the replacement valves eventually degenerate over time, so valve-in-valve has become See full press release