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Country-specific analysis will evaluate the cost effectiveness of an FFR-guided intervention strategy for patients with multivessel coronary artery disease in Japan, China, India, ...

Wed, 02/15/2012 - 3:45pm

ST. PAUL, Minn.--(BUSINESS WIRE)--Feb 15, 2012-- St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, announced today it will evaluate the incremental cost-effectiveness of Fractional Flow Reserve (FFR)-guided treatment for patients with multivessel coronary artery disease in Japan, China, India, Korea, and Australia. The analysis, which will also determine the potential health and budget impact that FFR-guided treatment provides for each of the countries, demonstrates the company's commitment to improving the health, welfare, and quality of life for the billions of people residing in these countries.

FFR measurements can be taken using the PressureWire(TM) Aeris or PressureWire(TM) Certus, and indicate the severity of blood flow blockages in the coronary arteries. This physiological measurement identifies which coronary narrowings are responsible for obstructing the flow of blood to a patient's heart muscle (called ischemia), and guides the physician in determining which lesions warrant stenting.

The detailed analysis will be based on the results of the landmark FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) study, statistics from country-specific percutaneous coronary intervention (PCI) registries and from published literature.

The research will reveal for each country the: -- Cost savings from using an FFR-guided approach to PCI -- Cumulative savings for the health care system annually -- Impact on health for the population undergoing PCI "All of the research that has been conducted in the U.S. and Europe regarding the benefits of using our PressureWire FFR measurement technology indicates that it improves clinical outcomes and saves money; we hope to discover similar outcomes in the Asian and Australian markets," said Frank J. Callaghan, president of St. Jude Medical Cardiovascular Division. "FFR represents a unique opportunity in medicine that aligns with the needs of government - to help make healthcare more affordable, and physicians - to improve care." St. Jude Medical provided an educational grant for similar research in Europe, with results revealing that the impact of FFR-guided treatment using the PressureWire technology can improve patient health while also significantly saving money. The analysis indicated that within the health care systems of Germany, the U.K., France, Italy and Belgium that the FFR-guided approach has the potential to reduce deaths and heart attacks as well as save between 500? and 950? per patient, depending on the country. Additionally, previous economic analysis determined that an FFR-guided intervention strategy reduced health care costs per patient by about $2,000, or 14 percent, in the context of the U.S. health care system.

The detailed analysis will be funded by an educational research grant from St. Jude Medical and led by professor Uwe Siebert, M.D., MSc, M.P.H., ScD and a FAME study co-author. Each country will also have local clinical advisors to help validate the data modeling.

"We believe that conducting this research will enable a better understanding of the broader economic and health impact that FFR-guided therapy may provide," Siebert said. "Having this knowledge on hand will help provide physicians, hospitals and governments with the information they need to decide on treatment options for ideal patient care." About the FAME Trial The FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) trial is a randomized, prospective, multi-center trial which enrolled 1,005 patients with multivessel coronary artery disease. The FAME study compared outcomes for patients whose treatment was guided by FFR to those whose treatment was guided only by angiography using St. Jude Medical's PressureWire Certus technology.

The 12-month results, published in the Jan. 15, 2009 issue of the New England Journal of Medicine, demonstrated that instances MACE were reduced by 28 percent for patients whose treatment was guided by FFR rather than by standard angiography alone. Two-year results demonstrated that patients who received FFR-guided treatment continued to experience improved outcomes over time, including a 34 percent reduction in risk of death or heart attack.

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. St. Jude Medical is headquartered in St. Paul, Minn. and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.

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 Annual Report on Form 10-K for the fiscal year ended January 1, 2011 and Quarterly Report on Form 10-Q for the fiscal quarter ended October 1, 2011. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

CONTACT: St. Jude Medical, Inc.

J.C. Weigelt Investor Relations 651-756-4347 jweigelt@sjm.com or Marisa Bluestone Media Relations 651-756-6739 mbluestone@sjm.com KEYWORD: AUSTRALIA UNITED STATES ASIA PACIFIC NORTH AMERICA AUSTRALIA/OCEANIA CHINA NORTH KOREA MINNESOTA SOUTH KOREA HONG KONG INDIA JAPAN INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY CARDIOLOGY CLINICAL TRIALS HOSPITALS MEDICAL DEVICES RESEARCH SCIENCE SOURCE: St. Jude Medical, Inc.

Copyright Business Wire 2012 PUB: 02/15/2012 08:01 PM/DISC: 02/15/2012 08:01 PM http://www.businesswire.com/news/home/20120215005009/

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