Lausanne, Switzerland, May 14, 2011 – Symetis SA, a private Swiss company developing new transcatheter aortic valve implantation (TAVI) systems, announced today during the Late-Breaking Trials session at EuroPCR 2011 (Paris – France), the 6 month results of its ACURATE TA™ first-in-man (FIM) clinical study. In addition, Symetis reported having enrolled 75 patients between its FIM and Pilot studies, sufficient to support the filing of its ACURATE TA™ CE mark application.
Details of the FIM study
The study - the largest 2nd generation TAVI FIM study ever conducted - 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%.
At 6 months, this novel 2nd generation transapical TAVI highlights a 87.5% survival rate, a PV Leak rate of 0 – 1 in 97% of followed patients and functional improvement from baseline in 90% of the cases with a NYHA Class I/II. At 6 months the pacemaker rate remains at 5%. In addition, with 35 patients enrolled as of today in its Pilot study, SYMETIS has completed the enrollment needed for its CE mark filing, which will occur in July. Market approval in Europe is expected by end of 2011. The company also expects to begin enrollment in the FIM study of its ACURATE TF™, its transfemoral system during Q4 2011.
Dr. Joërg Kempfert of the Kerckhoff Klinik in Bad Nauheim commented: “These 6 month data confirm that ACURATE TA™ is a promising alternative to already marketed products.”
Laura Brenton, VP Clinical / Regulatory Affairs, added: “The future of the ACURATE TA™ is bright with its comparable 6 month survival, low PV leak and increased functional improvement from baseline as compared to recently published related data.”
Jacques R. Essinger, CEO of Symetis, added: “We are very appreciative of our outstanding physicians and their expertise which supported the clinical development ACURATE TA™. We are looking forward to bringing this effective product to market and to further expand our presence into the transfemoral arena”
Symetis SA (www.symetis.com) is a private Swiss company developing innovative, minimally invasive heart valve replacement solutions. The company’s products, ACURATE TA™ and ACURATE TF™, based on proprietary geometry and delivery technologies, are well positioned to target the estimated $2 billion TAVI market. Based in Lausanne, the company is financed by leading European venture capital firms, including Truffle Capital, Novartis Venture Fund, Wellington Partners, Aravis Venture, Vinci Capital, Banexi Ventures, Endeavour Vision, NBGI Ventures and BiomedInvest.
For further information, please contact:
Dr. Jacques R. Essinger, CEO