Symetis has received CE-mark approval for its transfemoral transcatheter aortic valve implantation (TAVI) system Acurate Neo, which means it now offers (like market leaders Medtronic and Edwards Lifesciences) both transapical and transfemoral options for TAVI delivery. The company has now launched the product with its first commercial implantations.
A press release reports that Symetis conducted a single-arm, prospective, multicentre trial at six centres 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 six and 12 months. “With the transfemoral Acurate Neo, the Symetis team successfully duplicated the intuitiveuse and solid performance that are the hallmarks of its transapical system Acurate TA,” says principal investigator Helge Möllmann (Department of Cardiology, Kerckhof Klinik, Bad Nauheim, Germany).
The press release reports that the rollout of Acurate neo will be modelled on the successful commercialisation of Symetis’s transapical system, Acurate TA, which has witnessed a rapid uptake in core European markets.