Japanese Approve New Ring, Band for Heart Valve Repair
March 11, 2008 - St. Jude Medical Inc. received 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, allowing the company to offer its first valve repair solution in Japan.
The Tailor Flexible Ring and the C-shaped Tailor Flexible Band are designed to provide surgeons with a range of easy-to-implant options for the repair of the heart’s mitral and tricuspid valves.
The Tailor Flexible Ring and Band are engineered to accommodate the natural movement of the annulus, and physicians can reportedly 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.
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, according to statistics on thoracic and cardiovascular surgery (reported in the September 2007 issue of General Thoracic and Cardiovascular Surgery). It is estimated that surgeries to repair faulty valves will continue to increase as the average age of the population increases.
The Tailor Flexible Ring and Band previously have received regulatory clearance in the U.S. and Europe. The product will be launched immediately in Japan.
For more information: www.sjm.com