Six-month data of transcatheter aortic valve implantation with the Acurate TA device, have shown promising results in the TA-AVI first-in-man clinical study. Joerg Kempfert, Kerckhoff-Klinik Bad Nauheim, Germany, presented the results at a Late-Breaking Trials session at EuroPCR, in Paris, France.
Acurate TA is a new self-expanding nitinol stent for TAVI via transapical route. Based on a proprietary diabolo-like geometry combined with a unique reversible delivery sequence, Symetis’ Acurate TA system offers a controlled self-positioning of the valve after delivery. This feature makes the technology very tolerant with regard to implant positioning prior to full release, the company claims.
The TA-AVI study was conducted at five sites in Germany, including Herzzentrum Leipzig, Kerckhoff-Klinik Bad Nauheim, and Universitares Herzzentrum Hamburg. Forty patients with severe aortic stenosis were recruited and treated with an Acurate TA valve. The mean age of treated patients was 82.8±4 years, with a mean Logistic EuroScore of 21.5±10.9% and STS Score of 9±4.6%.
At six months, this second generation transapical device demonstrated an 87.5% survival rate, a perivalvular leak rate of 0–1 in 97% of the followed patients and functional improvement from baseline in 90% of the cases with a NYHA Class I/II, Kempfert told delegates.
“During the trial, the device has demonstrated proof of concept, with survival of 87.5% at six and 12 months, which is fairly good for a population with this high-risk profile. Functional improvement was also high, which is good for an elderly population like the one included in this study,” Kempfert said.
At six months, new pacemaker implantation rate remained at 5%, he added. In addition, with 35 patients enrolled as of May in its pilot study, Symetis has completed the total enrolment needed for its CE mark filing, expected to happen in July. Market approval in Europe is expected by the end of 2011. The company also expects to begin enrolment in the first-in-man study of Acurate TF, its transfemoral system, during the fourth quarter of 2011.
Kempfert concluded: “These six-month data confirm that Acurate TA is a promising alternative to products already on the market.”