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FAME Study Published in New England Journal of Medicine
Routine measurement of fractional flow reserve reduces the risk of death or heart attack by 35 percent after stent placement in patients with multivessel disease
UPPSALA, Sweden, & ST. PAUL, Minn., Jan 14, 2009 (BUSINESS WIRE) -- St. Jude Medical, Inc. (NYSE:STJ) today announced the publication of results from the landmark FAME (Fractional flow reserve (FFR) vs. Angiography in Multivessel Evaluation) study that demonstrate a statistically significant 30 percent difference in Major Adverse Cardiac Events (MACE) such as death, myocardial infarction and repeat revascularization. The randomized, prospective, multi-center trial looked at 1,005 patients with multivessel coronary artery disease 12 months after receiving a stent and compared outcomes for patients whose treatment was guided by FFR to those whose treatment was guided only by angiography.

Published in the Jan. 15 issue of the New England Journal of Medicine, the FAME study results show superior clinical and cost-effectiveness outcomes for the FFR-guided patient group for which investigators used a pressure sensor mounted on a guidewire, PressureWire(R) Certus, developed and marketed by Radi Medical Systems, which was acquired in December 2008 by St. Jude Medical.

In the study, the risk of a patient dying or having a heart attack was reduced by approximately 35 percent when FFR measurement was performed (11.1 percent for the angiography-guided group compared to 7.3 percent for the FFR-guided group, P=0.04). The 12-month overall MACE rate was 18.4 percent, compared to 13.2 percent for the FFR-guided group (p=0.02). This means that the likelihood of a patient having to return for further treatment (repeat stent placement or coronary artery bypass graft surgery) was significantly lower for the FFR-guided group.

In addition to the significant difference in MACE, the quality of life (freedom from angina and chest pain) for patients whose treatment was guided by FFR was equal to, and in some cases better than, that of patients whose treatment was based solely on angiography.

"Treatment decisions today should not be just about which stent you pick, they should be about where you put a stent," said the FAME study's co-principal investigator, Professor Nico Pijls, M.D., Ph.D., of Catharina Hospital in Eindhoven, the Netherlands. "We know that stenting ischemia-producing stenoses improves symptoms and outcomes, and that stenting non-ischemic stenoses has no benefit compared to medical treatment only. FFR is a simple measurement that can be performed quickly in the cath lab and makes it possible to treat culprit lesions only, while avoiding time, damage, and expense from placing stents which do not benefit the patient."

The FAME study is the first large-scale, randomized, prospective, multi-center clinical trial that compares stenting guided by FFR to stenting guided by angiography alone in patients with two or more diseased coronary arteries. The goal of the FAME study is to explore whether routine use of FFR can guide physicians to place stents optimally when assessing patients with multivessel disease. The FAME study was conducted in 20 centers in Europe and the United States and included 1,005 patients.

The FAME study also shows that FFR measurement is cost-saving and does not add time to the procedure. The average procedural costs were $5,332 for the FFR-guided group compared to $6,007 for the angiography-guided group (P<0.001). It took an average of 71 minutes to complete PCI in the FFR-guided group compared to 70 minutes in the angiography-guided group.

William F. Fearon, M.D., associate director of interventional cardiology at Stanford University Medical Center, Palo Alto, Calif., and co-principal investigator of the FAME study, added, "FAME confirms what previous smaller studies have suggested: that FFR-guided PCI improves outcomes and is cost-effective. Routine measurement of FFR in these complex patients significantly decreased the rate of death, myocardial infarction and the need for repeat revascularization compared to standard angiography-guided PCI. These results demonstrate the importance of revascularizing ischemia-producing lesions and medically treating hemodynamically insignificant ones."

"We are proud to be the exclusive sponsor of this landmark study that clearly documents a profound impact in improving outcomes of interventional cardiology procedures," said Anders Qvarnstrom, formerly COO of Radi Medical Systems AB, now part of the St. Jude Medical Cardiovascular Division. "As the inventor of PressureWire(R), the only pressure sensing guide wire used in FAME and the pivotal DEFER trial, we have long known of the impact of FFR on improving patient care and reducing costs and Drs. Pijls and Fearon have now published a remarkable study that confirms it. We are pleased to become a part of St. Jude Medical and to work to bring this technology to a broader physician community."

PressureWire(R) Certus has regulatory approval in Europe and Japan as well as Food and Drug Administration (FDA) clearance in the United States and is available to physicians in Europe, the U.S. and Japan.

About Fractional Flow Reserve (FFR)

Fractional Flow Reserve (FFR) is an index for functional severity of coronary stenoses as measured by PressureWire(R). The FFR threshold of 0.75 is 100 percent specific in identifying which lesion or lesions are responsible for a patient's ischemia (Ref. NEJM 1996), enabling the interventional cardiologist's direction of coronary interventions and results assessment for improved treatment outcomes.

About Radi Medical Systems

Radi Medical Systems develops, manufactures and sells medical devices designed to improve patient care. The company's pioneering work in the field of interventional cardiology has resulted in market-leading intravascular sensors and hemostasis management and radiology devices. The company was acquired by St. Jude Medical in December 2008, and is now part of the Cardiovascular Division of St. Jude Medical.

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 13,000 people worldwide and has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. For more information, please visit www.sjm.com.

St. Jude Medical 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, 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 December 29, 2007 and Quarterly Report on Form 10-Q for the fiscal quarter ended September 27, 2008. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

Editor's Note: Photographs and video of FFR measurement in the cath lab are available.

SOURCE: St. Jude Medical, Inc.

St. Jude Medical
Investor Relations
Angela Craig, 651-481-7789
Russo Partners
Media Relations
Ian Stone, 619-814-3510
Russo Partners
Media Relations
David Schull, 212-845-4271

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