Symetis has announced its Acurate TA and Acurate TF TAVI systems have been successfully implanted in patients in Japan as part of a feasibility study to secure the Pharmaceutical and Device Agency's (PMDA) pre-market approval.
Based on a proprietary hourglass-like geometry combined with a reversible delivery sequence, Symetis' Acurate TA system offers a controlled self-positioning of the valve after delivery.
This feature makes the technology tolerant with regard to implant positioning prior to full release.
The Acurate TA is available in three sizes to treat patients with aortic annulus diameters from 21mm to 27mm.
Based on the same self-positioning concept, Symetis' Acurate TF is designed for transfemoral delivery. It is currently under clinical investigation to obtain CE mark by end 2013.
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.
Acurate TF will be available in four sizes and its delivery system has an 18F outer diameter.
Symetis CEO Jacques Essinger said, "With some of the highest standards in cardiac surgery and interventional cardiology, and proportionally the largest elderly population worldwide, Japan is prone to embrace TAVI and represents an exciting opportunity to expand our clinical and commercial activity beyond Europe."
The easy, step-by-step delivery process for both the Acurate TA and Acurate TF provides the implanter with full control until final delivery. The positioning is intuitive with absence of paravalvular leak.