St. Jude Medical Enrolls First Patient in FAME II Clinical Trial to Study Use of Fractional Flow Reserve Technology in Patients With Stable Coronary Artery Disease

St. Jude Medical Enrolls First Patient in FAME II Clinical Trial to Study Use of Fractional Flow Reserve Technology in Patients With Stable Coronary Artery Disease
The Follow-up to the Landmark FAME Trial Will Examine Benefits of FFR-guided Stenting With Optimal Medical Treatment Compared to Optimal Medical Treatment Alone

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May 25, 2010 -- St. Paul, Minnesota -- St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, announced today at EuroPCR that the first patient was enrolled in the FAME II (Fractional Flow Reserve (FFR)-Guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment vs. Optimal Medical Treatment Alone in Patients with Stable Coronary Artery Disease) trial. The goal of the FAME II trial is to study the role of Fractional Flow Reserve (FFR) in the treatment of stable coronary artery disease by comparing the clinical outcomes, safety and cost effectiveness of percutaneous coronary intervention (PCI) guided by FFR plus optimal medical treatment (OMT) to OMT alone.

There are many different tools that aid physicians in the treatment of coronary artery disease. One tool is a coronary angiogram, which is an X-ray examination of the blood vessels or chambers of the heart. Another technology that aids physicians in making the best treatment decisions for their patients is the measurement of FFR, which provides a more detailed, physiological analysis of blood flow blockages in the heart. An FFR measurement of above .80 indicates stenting that particular lesion may not be beneficial, even though the narrowing may look severe on the X-ray.

Prior to randomization, all patients will have an FFR measurement of affected arteries using the St. Jude Medical PressureWire(TM) Certus or PressureWire(TM) Aeris. Patients found to have one or more ischemic lesion (FFR measurement below .80) will be randomized 1:1 to PCI and OMT or OMT only. Standard of care for OMT includes the use of aspirin, beta blockers, anti-anginal medicine, and drugs to reduce cholesterol in the blood; these treatments help the heart work more efficiently and receive more oxygen-rich blood. Patients with an FFR measurement indicating ischemia who are randomized into the PCI and OMT group will receive PCI with a stent, a small metal mesh tube that is inserted into an artery to reduce its narrowing and help restore normal blood flow, along with OMT.

The FAME II trial is a follow-up to the landmark FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) trial, which compared FFR-guided stenting using the St Jude Medical PressureWire(TM) to angiographic-guided stenting in patients with 2- or 3-vessel (multivessel) coronary artery disease. Results demonstrated superior clinical outcomes in patients whose treatment was guided by FFR prior to coronary stenting; after two years, the combined risk of death or myocardial infarction (heart attack) was 34 percent lower for patients whose treatment was guided by PressureWire technology. In addition to superior clinical outcomes, the FAME trial also demonstrated that after one year, the FFR-guided intervention strategy reduced health care costs per patient by about $2,000, or 14 percent.

The FAME II trial seeks to answer questions as to the benefits of coronary intervention raised by the recent COURAGE (Clinical Outcomes Utilizing Revascularisation and Aggressive Drug Evaluation) trial, which demonstrated no difference in the outcomes between PCI and OMT compared to OMT alone. However, the study did not include use of PressureWire technology to indicate the presence of ischemia. FAME II will explore whether FFR-guided interventions provide an added benefit to the treatment of patients with stable coronary artery disease.

"We expect the FAME II trial to provide further answers and evidence regarding the optimal way to treat patients with coronary artery disease," said Bernard De Bruyne, M.D., Ph.D., of the OLV Clinic in Aalst, Belgium, and coordinating clinical investigator of the FAME II trial. "I am optimistic that this large-scale, international trial examining the use of FFR will address the questions raised by the COURAGE trial about the clinical benefits of PCI by comparing FFR-guided treatment with optimal medical treatment."

Approximately 1,600 patients at 30 centers in Europe and the United States who have at least one hemodynamically significant lesion and are amenable to PCI with drug-eluting stents (unless contraindicated) will be enrolled in the FAME II trial. The prospective, multicenter, multinational, randomized trial's primary endpoint will be the 24-month major adverse cardiac event (MACE) rate, defined as all-cause death, documented myocardial infarction (heart attack) and unplanned hospitalization leading to urgent revascularization. Other endpoints include cost-effectiveness and functional status.

"The FAME trial demonstrated unequivocally that FFR-guided PCI interventions can improve patient outcomes by reducing the rate of mortality and heart attack in patients with multivessel coronary artery disease," said Frank Callaghan, president of the St. Jude Medical Cardiovascular Division. "St. Jude Medical is pleased to also sponsor the FAME II trial, which is an important next step to discovering the benefits of using FFR measurements in a new patient population."

The study's coordinating investigators are Bernard De Bruyne, Professor Nico Pijls, M.D., Ph.D., of Catharina Hospital in Eindhoven, the Netherlands and William F. Fearon, M.D., of Stanford University Medical Center in California.

EuroPCR is the official congress of the European Association of Percutaneous Cardiovascular Interventions (EAPCI), a leading international course for interventional cardiovascular specialists.

About Fractional Flow Reserve
Fractional Flow Reserve (FFR) is a physiological index used to determine the hemodynamic severity of narrowings in the coronary arteries, and can be measured using the PressureWire Aeris and PressureWire Certus. FFR specifically identifies which coronary narrowings are responsible for obstructing the flow of blood to a patient's heart muscle (called ischemia), and guides the interventional cardiologist in assessing which lesions warrant coronary interventions, resulting in improved treatment outcomes.

About the FAME Trial
The FAME study was a randomized, prospective, multi-center trial that enrolled 1,005 patients with multivessel coronary artery disease. It compared outcomes for patients whose treatment was guided by FFR to those whose treatment was guided only by angiography. The 12-month results, published in the January 15, 2009 issue of the New England Journal of Medicine, demonstrated that instances of major adverse cardiovascular events (MACE), including death, myocardial infarction or repeat revascularization, were reduced by 28 percent for patients whose treatment was guided by FFR rather than by standard angiography alone.

Two-year results presented as a late-breaking trial during the 2009 Transcatheter Cardiovascular Therapeutics (TCT) Conference demonstrated that patients who received FFR-guided treatment continued to experience improved outcomes over time, including a 34 percent risk reduction in death or myocardial infarction (heart attack).

FFR-guided treatment was also demonstrated to be cost-saving after one year, with a difference per patient of about $2,000, or 14 percent, between total health care costs for the FFR-guided group and the group treated by angiography alone. These lower health care costs were a result of reduced procedural costs, reduced follow-up costs for MACE and shorter hospital stays.

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 Quarterly Report on Form 10-Q for the fiscal quarter ended April 3, 2010. 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, Inc.