Symetis’ Aortic Bioprosthesis Receives CE Mark

Symetis SA, a private Swiss company developing new transcatheter aortic valve implantation (TAVI) systems, announced during the Techno-College at the EACTS (European Association for Cardio-Thoracic Surgery) meeting in Lisbon that it received CE Mark approval for its ACURATE TA™ transapical TAVI system. The approval of this 2nd generation TAVI device, used to treat elderly patients with severe aortic stenosis (AS) for whom open surgical repair is considered to be high risk, opens the company to a market estimated to exceed $2 billion by 2014.

CE Mark approval:
Symetis performed two clinical trials of the ACURATE TA™ in Germany: a FIM trial (n=40) and a Pilot study (n=50). The CE Mark was granted by the National Standards Authority of Ireland (NSAI, www.nsai.ie) using a composite of patients from both studies, including 65 patients followed at 30 days, 30 patients at 6 months and 10 patients at 1 year. The completion of enrolment in both studies translates to Symetis ACURATE TA™ having the largest clinical experience to date of any 2nd Generation TAVI device in clinical trials or approved for market. In addition, this dataset establishes a new standard for the approval of future 2nd generation TAVI systems.

Commercial launch:
The commercial launch of the ACURATE TA™ is taking place during the EACTS meeting, with an initial focus on Europe. In parallel, a 150-patient, 15-center Pivotal trial will be conducted to support the company’s US strategy. Also, a post-market surveillance study, SAVI (Symetis Aortic Valve Implantation Registry), will begin with implantation of commercial products.