Trial of second Symetis product successfully completed

Symetis Inc., a private Swiss company developing new transcatheter aortic valve implantation (TAVI) systems, announced during the PCR London Valves meeting that it finished enrollment (n=20) in its First-In-Man (FIM) trial of the transfemoral aortic valve replacement device, the ACURATE TF Aortic Bioprosthesis and Delivery System.
 
The FIM trial was conducted at four different centers in Brazil and Germany. The device was implanted with a procedure success rate of 95.0% (n=19) as one patient received a valve-in-valve procedure due to too low placement of the bioprosthesis in the LVOT. The Study PI, Prof. Helge Moellmann of the Kerckhoff Clinic in Bad Nauheim, Germany, stated: "this 2nd generation TF system has exhibited impressive results in its FIM trial already mirroring the ease of use of its commercially available transapical system, the ACURATE TA".
 
The CE-mark study has been initiated late September 2012 and the ACURATE TF system should receive a CE Mark mid 2013.
 
Based upon the same self-seating, self-sealing architecture and stepped deployment concept of its already marketed transapical sister product, the ACURATE TA Aortic Bioprosthesis, the 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. The bioprosthesis is available in three sizes (S, M, & L) to treat aortic annulus diameters from 21mm to 27mm and its Delivery System boasts an 18F outer diameter delivery catheter.