Five Year Data from the FAME Trial Further Confirms the Sustained, Long Term Benefit of FFR-Guided PCI over Angiography-Guided Intervention

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that five year results from the landmark FAME trial (Fractional Flow Reserve vs. Angiography in Multivessel Evaluation) have confirmed the long term benefits of fractional flow reserve (FFR) in guiding percutaneous coronary intervention (PCI) over angiography alone. An analysis of the study’s five year follow up data confirms that in patients with multi-vessel coronary artery disease, FFR-guided PCI can contribute to reductions in all-cause mortality, cardiac mortality and an overall use of health care resources.

The data, which were presented at the ESC Congress 2015, build upon previously-published results from the St. Jude Medical sponsored FAME trial at 12-months and two-year follow up intervals.

“Original 12 month results from the FAME trial and the study’s two year follow-up data demonstrated clearly that PCI guided by fractional flow reserve results in a significant reduction in major adverse cardiac events for patients undergoing PCI,” said the FAME study’s principal investigator, Nico H.J.Pijls, M.D., Ph.D., of Catharina Hospital in Eindhoven, The Netherlands. “Now, the study’s five year follow up data have given us a critical look at the impact of FFR guidance over time. We’ve proven that the benefits are sustained and can dramatically impact the long-term wellbeing and clinical outcomes of patients as compared to only using angiography to guide intervention.

After five years of patient follow up, FAME researchers have found that FFR guidance using St. Jude Medical PressureWire™ technology can lead to a more favorable treatment and clinical decision making, which can result in fewer events in the first two years and a sustained benefit up to five years. In addition, five year follow up data from the FAME trial demonstrate:

• Improved patient outcomes. In patients with multi-vessel coronary artery disease, FFR-guided PCI resulted in a 27 percent relative reduction of cardiac mortality versus angiography alone.
• An overall decline in adverse events. Adverse events among patients who received FFR-guided PCI consistently decreased compared to patients who received angiography-guided PCI.
• FFR’s positive economic impact on health care cost. Five year data from the FAME trial further supports the positive economic impact and reduction of health care resource utilization shown by the original results of the study.

“The five year data from the FAME study build upon our understanding of applying FFR to guide the care of patients battling coronary artery disease, and this study has continued to demonstrate that St. Jude Medical’s PressureWire technology can improve patient outcomes and the clinical benefits of PCI, while reducing costs for the health care system,” said Mark Carlson, M.D., chief medical officer at St. Jude Medical. “FFR technology provides physicians with the insight they need to make improved clinical decisions for their patients.”

Coronary artery disease is the most common form of heart disease and the leading cause of death for both men and women worldwide. The condition is caused by plaque build-up in the arteries, which can narrow blood vessels and block blood flow to the heart. During PCI procedures, FFR is used to provide physicians with a detailed analysis of the blood flow blockage to make decisions on how to best keep the artery expanded to restore blood flow to the heart and to determine whether coronary intervention – such as stenting, is necessary.

About the FAME Trial

The original FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) Trial compared outcomes of patients whose treatment was guided by FFR to those whose treatment was only guided by angiography. Results from the landmark trial demonstrated improved clinical outcomes in patients with stable coronary artery disease and two or three vessel disease.

The 12 month results published in the New England Journal of Medicine demonstrated that instances of major adverse cardiac events 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 risk reduction in death or heart attack.

About Fractional Flow Reserve

Fractional flow reserve is a physiological index used to determine the hemodynamic severity of narrowings (or lesions) in the coronary arteries, and is measured using St. Jude Medical PressureWire™ Aeris™ and PressureWire™ Certus™ FFR measurement system. FFR specifically identifies which coronary narrowings are responsible for obstructing the flow of blood to a patient’s heart muscle (called ischemia), and helps guide the interventional cardiologist in determining which lesions warrant stenting, resulting in improved patient outcomes and reduced healthcare costs.

About St. Jude Medical

St. Jude Medical is a global medical device manufacturer dedicated to transforming the treatment of some of the world’s most expensive epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. Headquartered in St. Paul, Minn., St. Jude Medical has four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com or follow us on Twitter @SJM_Media.

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 3, 2015 and Quarterly Report on Form 10-Q for the fiscal quarter ended July 4, 2015. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

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Contact information

St. Jude Medical, Inc.
Investor Relations:
J.C. Weigelt, 651-756-4347
jweigelt@sjm.com
or
Media Relations
Matt Puplett, 651-756-6293
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