Symetis Announces European Approval and Launch for the Transfemoral Acurate Neo TAVR System

September 12, 2014—Symetis SA announced the European launch of the Acurate Neo, a 15-F–compatible transfemoral transcatheter aortic valve replacement (TAVR) system that received CE Mark approval this summer.

On September 15 at 2:50 PM, Prof. Helge Möllmann, MD, will present a technology review, clinical results, and case examples of Acurate Neo as part of “Didactic Symposia: Aortic Valve Therapies—Today and Tomorrow” at TCT 2014: the 26^th Transcatheter Cardiovascular Therapeutics annual scientific symposium in Washington, DC. Prof. Möllmann served as principal investigator for the company’s trial of the device.

Symetis conducted a single-arm, prospective, multicenter trial at six centers of excellence in Brazil, Germany, and Japan, enrolling 89 high-risk patients with severe, symptomatic aortic stenosis who were considered at high risk or not eligible for open heart surgery. The primary endpoint of mortality at 30 days was 3.4%. Secondary endpoints included procedure success (95%) and safety and performance data collected at 30 days and at 6 and 12 months. More than 90% of the patient cohort was available at 12-month follow-up, noted the company.

In Symetis’s announcement, Prof. Möllmann commented, “With the transfemoral Acurate Neo, the Symetis team successfully duplicated the intuitive use and solid performance that are the hallmarks of its transapical system, Acurate TA.” Prof. Möllmann is from the Department of Cardiology at the Kerckhof Klinik in Bad Nauheim, Germany.

Prof. Alexandre Abizaid, MD, who conducted the Brazilian arm of the study, added, “I found the Acurate Neo to be one of the easiest and most predictable transfemoral self-expanding TAVR systems, and its clinical performance outstanding.” Prof. Abizaid is from the Institute Dante Pazzanese de Cardiologia in São Paulo, Brazil.

The Symetis transfemoral TAVR system includes the Acurate Neo aortic bioprosthesis and the Acurate TF transfemoral delivery system. The self-positioning bioprosthesis is composed of a porcine pericardial tissue valve sewn into a self-expanding nitinol stent covered with an antileak porcine pericardial skirt. The transfemoral delivery system is designed for a simple 3-step deployment and stable positioning within the native annulus.

The system is compatible with the 15-F Terumo SoloPath or 18-F Cook sheaths. The product is available in three sizes to treat patients with aortic annulus diameters from 21 mm to 27 mm, advised the company.