St. Jude Medical has gained regulatory approval from the Ministry of Health, Labor and Welfare (MHLW), in addition to reimbursement approval, of the SJM Tailor Flexible Ring and SJM Tailor Flexible Band, the company's first products in Japan for repairing diseased heart valves.
The Tailor Flexible Ring and the C-shaped Tailor Flexible Band are designed to provide surgeons with a range of implantable options for the repair of the heart's mitral and tricuspid valves, according the St. Paul, Minn.-based St. Jude.
The company said that its Tailor Flexible Ring and Band are designed to accommodate the natural movement of the annulus, and physicians can tailor the products to meet precise patient needs. The Ring provides anterior and posterior support of the valve while allowing necessary motion as the valve opens and closes, St. Jude said.
The September 2007 issue of the journal of General Thoracic and Cardiovascular Surgery that in 2005, the number of valve repair procedures performed in Japan increased more than 20 percent from the prior year, to nearly 6,400 procedures.
The Tailor Flexible Ring and Band previously have received regulatory clearance in the United States and Europe, and will be launched immediately in Japan.