Symetis bioprosthesis confirms superior results

Symetis Inc., a young Swiss med-tech company based in Ecublens, developing 2nd generation transcatheter aortic valve implantation (TAVI) systems, presented discharge and 30-day follow-up data from the Symetis ACURATE TA Valve Implantation (SAVI) Registry during the 79th Annual German Cardiac Society Meeting. SAVI is a post-market registry of the first 250 patients treated with the ACURATE TA that was granted CE mark in September 2011. The included patients were implanted at 17 centers in Germany, Switzerland, Argentina and Italy and reflect real-life clinical use of this 2 generation TAVI device.

Current efforts in TAVI are directed toward simplifying positioning and deployment, reducing procedure-related complications. The results of this post-market registry of the ACURATE TA reveal a high procedure success rate (98.0%) confirming the system’s unparalleled ease-of-use and nearly non-existent learning curve. Additionally, a very good safety profile and minimal PV leak rate as had already been observed in pre-market clinical trials of the device, were also reported.

The SAVI Registry shows a 30-day all-cause mortality rate of 6.8% - one of the lowest rates reported in registries of other transcatheter aortic valves (1-5). Hemodynamics and functional class improved solidly after the ACURATE TA implant procedure. Serious adverse events such as stroke (2.8%), myocardial infarction (0.8%), and new permanent pacemaker implantation (7.2%) rates were also very low. Furthermore, the ACURATE TA exhibits the lowest PVL reported in a TAVI registry with only 2.7% of patients with a PV leak ≥ Grade 2 at follow-up.

Prof. Thomas Walther MD, Kerckhoff Klinik, Bad Nauheim and Principal Investigator of the study, commented: “Patient safety is my highest priority. I am impressed by these real-world results and the consistent safety profile of ACURATE TA.