Valve-in-Valve Procedures With Medtronic's CoreValve Approved in Europe

May 23, 2013—Medtronic, Inc. (Minneapolis, MN) announced it has received CE Mark approval for valve-in-valve (VIV) procedures using the CoreValve and CoreValve Evolut transcatheter aortic valve replacement (TAVR) systems in degenerated bioprosthetic surgical aortic valves. The company noted that this regulatory approval for VIV procedures provides 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.

Medtronic noted that in November 2012, results from the Global VIV registry were published by Danny Dvir, MD, et al in Circulation (2012;126:2335–2344). The registry evaluated the safety and efficacy of the VIV approach in 202 patients at 38 sites in Europe, North America, Australia, New Zealand, and the Middle East.

In the study, 124 patients received the CoreValve system, which demonstrated superior hemodynamic outcomes and a procedural success rate of 96.8%. The data showed that the VIV approach's hemodynamic improvements included a decrease in valve gradients. Positive procedural outcomes were maintained at 1-year follow-up with 89% survival at 1 year, which was comparable with other non-VIV TAVR studies.

In Medtronic's press release, the GLOBAL VIV registry's lead investigator, Ran Kornowski, MD, commented, “While surgical valves provide effective therapy for many patients, the replacement valves eventually degenerate over time, so valve-in-valve has become a topic of great clinical interest due to the needs of these patients. European approval of the CoreValve procedure is a very important advance in the treatment of severe aortic stenosis and enables an entirely new group of patients to benefit from this transcatheter valve.” Dr. Kornowski is chair of cardiology at Rabin Medical Center and Tel-Aviv University in Tel-Aviv, Israel, and previously at Washington Hospital Center in Washington, DC.

Medtronic advised that the CoreValve VIV procedures are not approved in the United States, where the CoreValve system is available for investigational use only. In the Medtronic CoreValve United States Expanded-Use Study, the US Food and Drug Administration has approved investigational VIV procedures in extreme-risk patients as part of the pivotal trial evaluating the CoreValve system in the United States.