Healthcare Industry News:  Mitral Valve 

Devices Cardiology Regulatory

 News Release - March 2, 2010

St. Jude Medical Receives CE Mark Approval for Trifecta Valve

Next-generation Trifecta valve expands the company’s business into the pericardial aortic stented tissue valve segment

Approval marks continued progress in Company’s 30-year track record in heart valve replacement technology

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced that it has received CE Mark approval for the Trifecta™ valve, marking the Company’s launch into the market for pericardial aortic stented tissue valves.

The Trifecta tissue valve is used to replace a patient’s diseased, damaged or malfunctioning aortic heart valve, which controls blood flow from the heart to the rest of the body. The next-generation tissue valve has a tri-leaflet stented pericardial design which offers excellent hemodynamic performance, or nearly unobstructed blood flow, in order to mimic as closely as possible the flow of a natural, healthy heart. The unique valve design includes leaflets manufactured from pericardial tissue attached to the exterior of the valve stent which open more fully and efficiently to perform like a natural heart valve.

For more than 30 years, St. Jude Medical has offered patients the gold standard in mechanical heart valve performance and durability, and has developed the Trifecta valve using the same market-leading expertise. The valve’s titanium stent, which provides a fatigue resistant frame to support the valve within a patient’s heart, is covered with pericardial tissue to allow tissue-to-tissue contact when the leaflets open and close, which reduces the amount of wear and deterioration. Additional attributes contributing to the Trifecta valve’s durability include proprietary tissue fixation and St. Jude Medical’s patented Linx™ AC Technology, an anticalcification treatment designed to reduce tissue mineralization (hardening).

“The Trifecta valve’s superior hemodynamic performance helps to make it very attractive for aortic valve replacement, especially in a small aortic annulus,” said Professor Volkmar Falk, Chair of the Division of Cardiac and Vascular Surgery at University Hospital Zurich. “The construction and design of the Trifecta valve allows it to work seamlessly with the patient’s heart to generate adequate blood flow, which can offer patients an improved quality of life.”

With nearly 3.4 million patients in Europe suffering from aortic stenosis, the Trifecta valve is available in a wide range of sizes to offer physicians more control in choosing the appropriate replacement valve for each patient’s heart. The Trifecta stented tissue valve further expands St. Jude Medical’s valve product portfolio which includes market-leading mechanical heart valves, valve annuloplasty rings and porcine tissue valves with superior durability for both the aortic and Mitral Valve.

“St. Jude Medical has long been dedicated to the development of heart valves that offer patients a best-in-class option for their care. For many years we have dedicated significant resources to develop better heart valve replacement technology, and the Trifecta valve is one culmination of that effort. Trifecta has been specifically designed for improved hemodynamics, durability and implantability, and we are proud to offer it to the cardiac surgery community,” said Frank Callaghan, president of St. Jude Medical’s Cardiovascular Division. “The Trifecta valve marks an important milestone for St. Jude Medical, and it reflects our commitment to developing products which improve physician control, reduce patient risk and improve patient outcomes.”

About St. Jude Medical

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, Minn., St. Jude Medical employs more than 14,000 people worldwide and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. 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 Risk Factors and Cautionary Statements sections of the Company’s Quarterly Reports on Form 10-Q for the fiscal quarters ended April 4, 2009, July 4, 2009 and October 3, 2009. 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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