ACURATE TA Aortic Bioprosthesis Shows Promise

SAN FRANCISCO, CALIF.—A new self-expanding aortic bioprosthesis was linked to high procedural success at 30 days, according to a presentation at TCT 2011.

Jöerg Kempfert, MD, of Kerckhoff Clinic Bad Nauheim, in Germany presented early findings for the Acurate TA (Symetis), a self-expandable bioprosthesis for the transcatheter treatment of native annuli ranging from 21 mm to 27 mm in elderly high-risk patients. “The device is available in three different sizes,” Kempfert said.

The device is repositionable and self-aligning and is composed of a biologic porcine tissue valve, a self-expandable nitinol stent and a PET skirt to reduce paravalvular leakage. “The stabilization arches at the top are there to prevent tilting at the time of implant,” Kempfert said.

The sheathless delivery is conducted in two steps, both of which involve a turn of the delivery system and device. “The first turn is a partial release that releases the upper crown of the device,” Kempfert said. “The second turn is a full release that releases the valve body.”

After outlining the specifications and implantation procedure, Kempfert highlighted 30-day data from the pilot study, which involved 50 NYHA class III/IV patients with a logistic EuroScore of 19.4% and an STS score of 7.9 (see Table).

In addition, 86% of patients showed symptomatic improvement. There were 2 fatalities. Kempfert noted that one of them involved annular rupture on day 3 after implantation, and the other involved respiratory failure on day 27.

“No patients experienced a leak of greater than 2,” Kempfert added.

The device received CE mark approval in Europe in September 2011. An ongoing post-marketing surveillance study involving 150 patients is currently being conducted in the EU. The transfemoral first-in-man data are expected in early 2012.