St. Jude Medical (NYSE:STJ) announced Tuesday that it has won Japanese regulatory approval to market a new smaller heart valve in Japan.
The new Trifecta aortic stented, pericardial tissue valve has been implanted in procedures at Osaka University Hospital and Saitama Medical University International Medical Center, according to the company.
To ensure the structural integrity of the valve, the Trifecta valve is made from a polyester and tissue-covered titanium stent, or base. The valve has leaflets manufactured from bovine and porcine pericardial tissue that are attached to the exterior of the valve stent. St. Jude believes this design allows the leaflets to open more fully and efficiently, and mimics the performance of a healthy aortic heart valve and limits tissue abrasion through stent-to-leaflet contact.
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“The smaller valve is more suitable for Japanese patients and also offers exceptional hemodynamic performance, which allows it to perform more like a natural heart valve,” said Dr. Yoshiki Sawa of Cardiovascular Surgery at Osaka University Hospital, in a St. Jude news release.
The Trifecta valve was approved by the U.S. Food and Drug Administration last year.