Symetis has announced the first-time implantation of its ACURATE TA and ACURATE TF transcatheter aortic valve implantation (TAVI) devices in Japan. The procedures were performed at Osaka University Hospital, Japan, with four patients successfully treated in an initial feasibility study.
The four patients were treated by Toru Kuratani, with two patients receiving a transapical ACURATE TA valve and two patients receiving a transfemoral ACURATE TF valve. According to a press release, immediate post-operative results demonstrated excellent outcomes, with all valves presenting zero or trace paravalvular leak, single-digit gradient and no complications.
Yoshiki Sawa, who will be the principal investigator of an upcoming study to support filing for Japanese Pharmaceutical and Device Agency (PMDA) approval, stated: “This is the first time that a second generation TAVI was implanted in Japan and we are proud to lead this clinical effort to bring the ACURATETM TAVI systems to our patient population. These cases also marked our 100th TAVI implantation at Osaka University Hospital.”