Symetis has received the CE mark approval for its Acurate TA transapical transcatheter aortic valve implantation (TAVI) to treat elderly patients with severe aortic stenosis (AS).
The approval of the Acurate TA was based on the results of the two clinical trials conducted in Germany including FIM trial (n=40) and a Pilot study (n=50).
Both studies are multicenter, prospective and single-arm trials which enrolled high-risk patients with severe AS.
The primary endpoint of both studies is 30-day mortality.
Primary endpoints included procedure success (95%) and safety/performance data collected at 30 days, 6 months and 1 year.
The secondary endpoints are Macce, as well as Echo parameters evaluating performance of the Acurate TA.
Study principal investigator Thomas Walther said patients had good functional outcome with low level of paravalvular leak, which may be a good prognostic factor for long-term favorable outcomes.
Symetis CEO Jacques Essinger said while they will now expand their clinical experience through commercialization of their Acurate TA maintaining the required level of clinical result will drive their commercial strategy.