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St Jude Medical receives Japanese approval for heart valve repair devices

St Jude Medical : 10 March, 2008  (New Product)
St Jude Medical has received regulatory approval from Japan’s Ministry of Health, Labor and Welfare (MHLW), in addition to reimbursement approval, of the SJM Tailor Flexible Ring and SJM Tailor Flexible Band.
The two devices are St Jude Medical’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 easy-to-implant options for the repair of the heart's mitral and tricuspid valves.

Malfunctioning heart valves sometimes can be repaired rather than replaced. Heart valves keep blood flowing in one direction, into or out of the heart. When they become diseased (due to infection, damage from a heart attack, a congenital condition or other cause), the shape of the valve's annulus, a fibrous ring that surrounds the opening of the valve, can change. This causes the valve's leaflets to become misaligned, preventing the valve from closing tightly.

Valves that do not securely close may allow blood to regurgitate, or ‘leak’ backward. Left untreated, regurgitation can lead to irregular heartbeat, clotting, stroke and heart failure.

The 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.

'With the approval and introduction of the Tailor Ring and Band, St Jude Medical is offering its first valve repair solution in Japan, building on our long-established tradition of assisting Japanese surgeons with safe and effective solutions for the treatment of valve disease,' said Paul Bond, president, St Jude Medical Japan.

St Jude Medical is currently the leading supplier of mechanical heart valves in Japan.

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 USA and Europe. The product will be launched immediately in Japan.
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