Figure 3 Fluorouracil manufacturer Symetis Acurate TA™ Aortic Bioprosthesis.Courtesy of Symetis SA, Lausanne, Switzerland. Symetis received CE Mark approval for the Acurate transapical TAVI system at the end of September 2011. The prosthesis has shown promising results with a 30-day survival rate of 92% in the first 90 patients.12 The commercial launch of the transapical Acurate valve took place during
Inhibitors,research,lifescience,medical the European Association for Cardio-Thoracic Surgery meeting in Lisbon/Portugal in October 2011, with an initial focus on Europe. In parallel, a 150-patient, 15-center pivotal trial will be conducted in the United States. The CE Mark trial for the transfemoral version of the Symetis Acurate will be finished until August 2012. St. Jude Medical Portico™ Aortic Valve The Portico valve (St. Jude Medical, St. Paul, Minnesota) is comprised of leaflets made of bovine pericardial tissue that have been treated with anti-calcification technology and sutured in a nitinol self-expanding stent. This valve is designed for transfemoral (18-Fr delivery system
via transfemoral sheath) and Inhibitors,research,lifescience,medical transapical use (24-Fr delivery system with integrated sheath) (Figure 4). The open cell design of the stent frame allows access to the coronaries and a low crimp profile. A tissue cuff at the lower part of the valve frame Inhibitors,research,lifescience,medical has been designed to minimize periprosthetic AR. After deployment of the valve, the prosthesis frame only minimally protrudes Inhibitors,research,lifescience,medical into the left-ventricular outflow tract, which is made possible by the low placement of the leaflets within the stent frame. This might help to reduce significant
conduction system interference and the need for pacemaker implantation. The Portico valve can be completely resheathed, allowing it to be repositioned at the implant site or retrieved before it is released from the delivery system. A first-in-man study with 10 patients evaluated the technical feasibility, safety, and device deployment characteristics of the 23-mm Portico valve transfemoral delivery system. The study Inhibitors,research,lifescience,medical showed promising results at 30 days, with no device- or procedure-related adverse events or death and only trivial or no paravalvular leak. Both a European and US trial are planned for 2012. Figure 4 St. Jude Medical Portico™ Transcatheter Aortic Heart ValveCourtesy of St. Jude Medical, St. Paul, Minnesota. Edwards Chlormezanone SAPIEN® 3 and Edwards CENTERA Aortic Valve Edwards (Edwards Lifesciences, Irvine, California) will unveil two next-generation transcatheter heart valve platforms in 2012. The Edwards SAPIEN 3 is a lower profile, balloon-expandable valve that is designed to further reduce paravalvular leak. For percutaneous use, this valve has treated bovine pericardial tissue leaflets and is delivered through a 14-Fr sheath that might help to further reduce vascular complications. The profile for the transapical approach will also be reduced considerably.