Healthcare Industry News:  neuromodulation 

Devices Cardiology Regulatory

 News Release - March 10, 2008

St. Jude Medical Announces Japanese Approval and Launch of Tailor Flexible Ring and Band for Heart Valve Repair

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced 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 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 heart beat, 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 Co., Ltd. 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 United States and Europe. The product will be launched immediately in Japan.

About St. Jude Medical

St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The Company has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 12,000 people worldwide. For more information, please visit

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings, and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company’s control and the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Company’s Annual Report on Form 10-K filed on February 27, 2008 (see Item 1A on pages 13-20, and page 20 of Exhibit 13 to the Company’s Form 10-K). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

Source: St. Jude Medical

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