FDA Approves Valve-in-Valve Procedures With CoreValve TAVR System

March 31, 2015—Medtronic plc announced US Food and Drug Administration (FDA) approval of the CoreValve transcatheter aortic valve replacement (TAVR) system for valve-in-valve (VIV) procedures in both high- and extreme-risk patients whose surgical aortic heart valves have failed. 

The company stated that during the VIV procedure, the CoreValve system is placed inside a failing surgical heart valve with an inner diameter of 17 to 29 mm through a low-profile, 18-F delivery catheter. The delivery system is approved for use with all four CoreValve sizes (23, 26, 29, and 31 mm) and for three delivery approaches (transfemoral, subclavian, and direct aortic).

According to Medtronic, the CoreValve system is engineered with a supra-annular valve design that helps maximize blood flow for patients whose artificial heart valves have shown stenosis, regurgitation, or both. Outcomes from an expanded-use study, an observational arm of the CoreValve United States Pivotal trial, demonstrated low rates of mortality and stroke (a combined rate of 4.2% at 30 days and 10.7% at 6 months), as well as significant improvements in hemodynamics and quality of life in patients with failed surgical heart valves. 

The company noted that results from the Global VIV registry showed that the VIV approach resulted in considerable hemodynamic improvements, including a decrease in blood flow resistance. In this registry, positive procedural outcomes were maintained at 1-year follow-up with 89% survival, which is comparable with other non-VIV TAVR studies, stated Medtronic. The Global VIV registry was published in November 2012 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. 

European CE Mark approval for VIV procedures with the CoreValve system was announced in May 2013. The CoreValve system first received European approval in 2007. In 2014, the FDA approved the CoreValve TAVR system for patients at extreme and high risk for surgery.