Symetis AG Completes Enrollment, Obtains Positive Preliminary Results for First-in-Man Clinical Study of ACURATE TA(TM) Aortic Valve Replacement System
9/23/2010 7:09:07 AM
LAUSANNE, SWITZERLAND--(Marketwire - 09/23/10) - Symetis SA, a private Swiss company developing new transcatheter aortic valve implantation (TAVI) systems, announced today the completion of patient enrollment in its ACURATE TA™ first-in-man (FIM) clinical study and positive preliminary results. ACURATE TA™ is a self-aligning nitinol stent valve designed for optimal trans-apical delivery, providing the physician with unmatched positioning tolerance and ease of use.
Details of the study
The study -- the largest FIM study ever sponsored by any 2nd generation TAVI company -- was conducted at 5 sites in Germany: Leipzig Herzzentrum, Kerckhoff-Klinik Bad Nauheim, Freiburg UniversitätsSpital, Westdeutsches Herzzentrum Essen and Universitäres Herzzentrum Hamburg. Forty (40) patients with severe aortic stenosis were recruited and treated with ACURATE TA™. The average age of treated patients was 83 years with a mean Logistic EuroScore of 21.5% and STS Score of 9.0%.
Successful valve implantation with the ACURATE TA™ occurred in 38 patients (95.0%). One patient received a valve-in-valve using a commercially available transapical valve and one patient was converted to sAVR. Only one patient required a new pacemaker post-implant. 30-day mortality was 12.5% including 3 deaths from non-valve-related respiratory complications. Comprehensive 30-day results will be presented at the Dallas / Leipzig International Valve conference in December 2010.
Pr. Thomas Walther of Kerckhoff-Klinik Bad Nauheim commented: "The ACURATE TA™ is truly intuitive, easy to use, reliable and covers the full spectrum of severe aortic stenosis. We look forward to the Pilot study to confirm the excellent results obtained in this comprehensive FIM study."
Laura Brenton, VP Clinical / Regulatory Affairs, added: "The ease of use of the ACURATE TA™ was acknowledged by all physicians participating in the study. Additionally, the learning curve was significantly shorter than that of competitive systems. Furthermore, the robust size of the FIM allows for comparison of its initial data to published statistics from competitors suggesting comparable or improved initial outcomes."
Jacques R. Essinger, CEO of Symetis, added: "ACURATE™ TA is the second generation TAVI system with the largest clinical experience to date. We are building on this competitive advantage by soon beginning a pilot clinical study, a major step toward achieving European compliance and the CE marking."
Symetis SA (www.symetis.com) is a private Swiss company developing innovative, minimally invasive heart valve replacement solutions. Symetis's Acurate TA™ system, based on proprietary geometry and delivery technology, is in clinical trials and is well positioned to target the ca. $2 billion transcatheter aortic valve implantation (TAVI) market. The company is financed by leading European venture capital firms including Truffle Capital, Novartis Venture Fund, Aravis Venture, Wellington Partners, Vinci Capital, Banexi Venture and BiomedInvest.