Economic Evaluation of FAME Trial Confirms Using FFR in Treatment of Coronary Artery Disease Is Cost-Effective

Results demonstrate FFR-guided treatment offers cost-saving benefits to the U.S. healthcare system

ST. PAUL, Minn.--(BUSINESS WIRE)-- St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the publication of results from an economic evaluation of the landmark FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) trial, which confirmed FFR-guided percutaneous coronary intervention (PCI) in patients with multivessel coronary artery disease improves patient outcomes and offers cost-saving benefits to the U.S. healthcare system.

The one-year results, published in Circulation, demonstrate that treatment guided by St. Jude Medical’s FFR measurement system was cost-saving, finding mean overall costs associated with the FFR-guided group significantly lower than the group guided by angiography alone. Mean overall costs for FFR-guided treatment was $14,300, compared to $16,700 for angiography-guided treatment, with cost savings occurring during both the initial procedure, primarily due to a decrease in unnecessary drug-eluting stent use, and during follow-up as a result of a decrease in re-hospitalization and fewer major adverse cardiac events (MACE). Results further indicated that MACE, such as death, myocardial infarction (heart attack) and repeat revascularization, occurred in 13.2 percent of patients who received FFR-guided treatment, compared to 18.3 percent of patients who received angiography-guided treatment.

“Economic evaluation of the FAME study reveals that FFR-guided percutaneous coronary intervention in patients with multivessel coronary disease is one of those rare situations in which a new technology not only improves outcomes but also conserves resources,” said William F. Fearon, M.D., associate professor, Stanford University Medical Center. “This study also reflects the benefits this technology has on patient care and the advantages it offers to the healthcare system as a whole.”

Current data show that physiological assessment using FFR prior to placement of coronary stents helps physicians to 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). In addition, data have demonstrated that FFR measurements can be useful as an alternative to noninvasive functional testing, and to help assess an abnormal narrowing in a coronary artery for patients with anginal symptoms such as chest pain.

“St. Jude Medical believes FFR provides tremendous value to patients, physicians and hospitals,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division. “Not only is it clinically effective, but it is clear that it is a cost-effective treatment option for hospitals. We will continue to provide physicians with data that further demonstrate the significant benefits this technology offers for patients and healthcare systems around the world.”

The FAME study is a randomized, prospective, multi-center trial which enrolled 1,005 patients with multivessel coronary artery disease. The study 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 MACE were reduced by 28 percent for patients whose treatment was guided by FFR rather than by standard angiography alone. Based on its large size, multicenter nature, and randomized prospective design, the economic evaluation of the FAME trial further strengthens the evidence supporting the health economic advantage to performing FFR-guided percutaneous coronary intervention.

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 heart attack.

The St. Jude Medical FFR measurement system portfolio includes both the PressureWire™ Certus and the PressureWire Aeris™. The PressureWire Certus was the only FFR guidewire 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 October 2, 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.



CONTACT:

St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Investor Relations
[email protected]
Kate Stoltenberg, 651-756-6293
Media Relations
[email protected]

KEYWORDS:   United States  North America  Minnesota

INDUSTRY KEYWORDS:   Health  Cardiology  Clinical Trials  Hospitals  Medical Devices

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