Symetis

Symetis

October 28, 2013 03:00 ET

Symetis Announces a Symbolic Milestone: the 1000th Patient Implanted with ACURATE TA™

- SAVI 2 Registry to further support Symetis TA franchise

- Valve-in-valve clinical study to extent ACURATE TA label

ECUBLENS, SWITZERLAND--(Marketwired - Oct. 28, 2013) - Symetis Inc., a privately-owned Swiss company focused on transcatheter aortic valve implantation (TAVI) systems announced today that it has achieved a symbolic milestone: the implantation of the 1000th ACURATE TA™ transaortic valve.

The first ACURATE TA™ valve was implanted in November 2009 at the Leipzig Herzzentrum by Pr. T. Walther and Dr. J. Kempfert. ACURATE TA™ was granted CE mark in September 2011 and the first commercial implant was performed in November 2011. In April 2012, Symetis reported the clinical outcome of its SAVI Registry (n=250) showing superior results in the patient population treated in everyday clinical settings: more than 97% of patients with no relevant paravalvular leak (PVL ≤1), procedural success rate 98% and stroke rate below 2%. During the recent EACTS 2013 in Vienna (Austria), the versatility of the ACURATE TA™ system was further demonstrated by Pr. Michael Hilker (Universitätsklinikum Regensburg) as an effective solution to failed biological valves (valve-in-valve) and by Dr. Wendt (Universitätsklinikum Essen) as a safe and effective treatment for aortic insufficiency. Since its first use, ACURATE TA™ has been implanted to date in over 1000 patients in Europe, Argentina and Japan.

To further support its transapical franchise, Symetis will soon initiate two new studies: the SAVI II Registry, which will include echocardiography core lab analysis and a valve-in-valve study to expand the label indication of ACURATE TA™ for this growing medical need.

"I want to express the company' gratitude to all those physicians who trusted our company and our team, and helped us achieve this milestone, which definitively sets Symetis among the established TAVI players," said Jacques R. Essinger, CEO of Symetis. "

"The concept was clearly right from the beginning," commented Pr. T. Walther, now at the Kerckhoff-Klinik in Bad Nauheim. "It took however some small but essential adjustments to make the ACURATE TA™ an outstanding transapical system - one that we now use routinely in our clinic. It has been a pleasure to work with the Symetis team who have been so responsive to our comments." PD Dr. H. Treede (Universitäres Herzzentrum Hamburg ), who was among the ACURATE TA™ first-in-man study investigators, added: "I remember my comment after the first two cases: easy. In the meantime, the ACURATE TA™ system has proven itself by producing superior and reliable clinical outcomes."

"We believe that the key to TAVI success is a combination of ease of use and clinical performance. Thanks to the Symetis R&D team and the essential input from our early users, we have achieved this winning combination. We are however committed to further perfect our results - our recent ActiveSeal technology licensing to achieve the company's ZeroLeak vision is a testimony to that," said Jacques R. Essinger. "To have treated 1000 patients in little more than two years in a highly competitive environment is confirmation of our strong company quality. This milestone sets us on the path towards further powerful growth."

About ACURATE TA™ & ACURATE TF™

The commercially available, self-expanding ACURATE TA™ has a unique and intelligent design featuring a two-step single operator deployment technique. The most important differentiator is the "self-seating and self-sealing" design combined with outstanding ease-of-use throughout the procedure. This contributes to optimal positioning of the valve and promotes sealing, hence reduces paravalvular leak. The ACURATE TA™ is available in three sizes (S, M, L) to treat patients with aortic annulus diameters from 21mm to 27mm.

ACURATE TF™, Symetis' transfemoral TAVI system, is based on the same self-seating, self-sealing design and stepped deployment concept of ACURATE TA™ and currently is under clinical investigation to obtain CE mark by end 2013. ACURATE TF™ is composed of a porcine pericardial tissue valve sutured within a self-expanding nitinol stent covered by a pericardial skirt on the interior and exterior of the device. ACURATE TF™ will be available in four sizes (XS, S, M, L) and its Delivery System boasts an 18F outer diameter.

For more information on ACURATE TA™ and ACURATE TF™, please see www.pcronline.com/redirect/2013-EuroPCR-Symetis/.

About Symetis

Symetis SA is a privately-owned Swiss company developing innovative, transcatheter heart valve replacement solutions (www.symetis.com). The company's products, ACURATE TA™ and ACURATE TF™, are based on proprietary geometry and delivery technologies and 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.

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