New 2010 ESC Guidelines for Percutaneous Coronary Interventions Reinforce Importance of FFR in Treatment of Coronary Artery Disease

FFR is updated to Class 1, level of evidence A, the highest class and level possible; update was driven by the positive results of the landmark FAME trial

ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ) applauds the updated class and level of evidence for Fractional Flow Reserve (FFR)-guided treatment in the Guidelines on Percutaneous Coronary Intervention (PCI) announced Monday at the European Society of Cardiology (ESC) congress in Stockholm. Supporting this change are the very strong one and two year data from the landmark FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) trial, which demonstrated improved outcomes for patients with multivessel coronary artery disease whose treatment was guided by St. Jude Medical FFR Measurement Systems rather than by standard angiography alone.

“This announcement reinforces the value of FFR as a technology that benefits patients, improves clinical outcomes and reduces the overall cost of treatment.”

The ESC guidelines, which are intended to assist health care providers in clinical decision making, now classify FFR-guided treatment as “Class I, with level of evidence A.” Level of evidence A is the highest level available, requiring the most clinical evidence, and is awarded only when data has been derived from multiple randomized clinical trials or meta-analyses. Class I indicates a general agreement that a given treatment or procedure is beneficial, useful, and effective.

Stefan James, M.D., associate professor of cardiology at Uppsala University Hospital in Uppsala, Sweden, and a member of the ESC Guidelines task force for myocardial revascularization, commented on the update, stating, “The overall aim of the new guidelines for both percutaneous and surgical revascularization has been to shift emphasis from using primarily the anatomical expression of coronary artery disease to guide treatment toward a more patient oriented perspective, where all aspects of the disease are taken into account. In this context, the physiological impact of coronary lesions and FFR-measurements play a central role.”

Current data show that physiological assessment using FFR prior to placement of coronary stents helps physicians better optimize clinical outcomes by determining which specific lesion or lesions are responsible for a patient’s ischemia, a deficiency of blood supply to the heart caused by blood restriction. The recommendations supported by a level of evidence A state that FFR measurements can be useful in assessing whether an intervention in a coronary lesion is necessary, as an alternative to noninvasive functional testing, and to help assess intermediate stenosis in patients with anginal symptoms.

“Given the long-term investments St. Jude Medical continues to make in lesion assessment technology, including FFR, we are pleased to see the updated guidelines for this significant technology,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division. “This announcement reinforces the value of FFR as a technology that benefits patients, improves clinical outcomes and reduces the overall cost of treatment.”

The FAME study was a randomized, prospective, multi-center trial which 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), such as death, myocardial infarction or repeat revascularization, were reduced by 30 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 of death or myocardial infarction (heart attack). FFR-guided treatment was also demonstrated to be cost-saving, with a difference of about $2,000, or 14 percent, between total healthcare costs for the FFR-guided cohort and the group treated by angiography alone. These lower healthcare costs were a result of reduced procedural costs, reduced follow-up costs for major adverse cardiac events and shorter hospital stays.

St. Jude Medical’s FFR Measurement System portfolio includes both the PressureWire Certus and the PressureWire Aeris™. The PressureWire Certus was the only FFR Measurement System used in the FAME trial; the PressureWire Aeris is the industry’s only wireless technology available, which requires no additional equipment or cabling in the cardiac catheterization laboratory.

About Fractional Flow Reserve (FFR)

Fractional Flow Reserve (FFR) is an index determining the functional severity of narrowings in the coronary arteries as measured by PressureWire Certus and PressureWire Aeris. FFR specifically identifies which coronary narrowings are responsible for significantly obstructing the flow of blood to a patients’ heart muscle (called ischemia), and it is used by the interventional cardiologist to direct coronary interventions and assess results for improved treatment 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. 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.