Symentis, a company out of Écublens, Switzerland, won CE Mark approval to introduce its ACURATE neo transcatheter aortic heart valve in the EU. The valve is delivered via the transfemoral route and is compatible with 15 French balloon-expandable and 18 French rigid sheaths.
It’s made out of three porcine pericardial leaflets on top of a nitinol stent.
Some info from a study of the ACURATE neo valve from Symentis’ announcement:
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 high-risk or non-surgical candidates for open-heart surgery. The primary endpoint was mortality at 30 days (3.4%). Secondary endpoints included procedure success (95%) and safety and performance data collected at 30 days, and at 6 and 12 months.
“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™,” said principal investigator Prof. Helge Möllmann from the Department of Cardiology at the Kerckhof Klinik, Bad Nauheim, Germany.
“I found the ACURATE neo to be one of the easiest and most predictable transfemoral self-expanding TAVI systems, and its clinical performance outstanding,” said Prof. Alexandre Abizaid, from the Institute Dante Pazzanese de Cardiologia in São Paulo, Brazil, who conducted the Brazilian arm of the study.
Product page: ACURATE neo…
Press release: Symetis receives CE Mark approval for transfemoral transcatheter aortic heart valve system ACURATE neo™…