CE Mark approval in September 2011 and to date over 100 commercial implants have been performed. The device is composed of a porcine biologic valve attached to a self-expanding nitinol stent designed for simple 2-step implantation and characterized by controlled positioning, self-seating in the native annulus resulting in a negligible paravalvular leak rate. The device was tested in patients at high-risk for mortality with open surgical repair. Methods: Ninety (90) patients (femaleϭ69%) with severe aortic stenosis, a mean age of 83.4 Ϯ 4.1 years, all presenting with NYHA Functional Class III or IV and a mean STS Score of 7.9 Ϯ 4.6 were enrolled in two studies in Germany at 6 centers. Patients are clinically followed at 7 and 30 days, at 6 and 12 months, and annually thereafter out to 5 years post-implant. The device was successfully implanted in 94.4% of patients (nϭ85) with a pacemaker implantation rate of 11.1% (nϭ10). Results: At 12 months the survival rate is 81.1% (nϭ73), the stroke rate is 4.4% (nϭ4), with no further re-intervention required on the implanted device since procedure. Of the returning patients, 87% presented with NYHA Functional Class I/II. The mean gradient at 6 months is 10.3 Ϯ 5.2 mmHg, the mean EOA is 1.5 Ϯ 0.4 cm2 and 77.3% of returning patients suffered no paravalvular leak, 21.2% exhibit mild paravalvular leak (ϩ1) and only 1 patient possesses a moderate paravalvular leak (ϩ2). Conclusions: These data confirm the safety profile at one year of this 2nd Generation TAVI system. We will report the full 12 months results of this multi-center, nonrandomized study of this transapically-placed transcatheter aortic valve at TCT 2012.

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