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TMCNet:  New Clinical Trial Results Demonstrate Importance of St. Jude Medical Fractional Flow Reserve in Guiding Treatment of NSTEMI Patients

[September 01, 2014]

New Clinical Trial Results Demonstrate Importance of St. Jude Medical Fractional Flow Reserve in Guiding Treatment of NSTEMI Patients

ST. PAUL, Minn. & BARCELONA, Spain --(Business Wire)--

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced a new multi-center clinical trial has found that using St. Jude Medical Fractional Flow Reserve (FFR) technology changed the course of treatment for more than one fifth of patients suffering non-ST segment elevation myocardial infarction (NSTEMI) heart attacks. The data also demonstrated that FFR-guided PCI (News - Alert) is safe and tended to reduce procedure-related myocardial infarctions in NSTEMI patients over angiography alone. NSTEMI is the most common form of acute coronary syndrome and a leading cause of premature morbidity and mortality worldwide.

The data were presented during a hot line late-breaking session at the European Society of Cardiology Congress 2014 and appears in the online version of the European Heart Journal.

FFR technology allows physicians to more accurately assess the severity of blood flow blockages in the coronary arteries and determine which lesions require treatment. Previous clinical studies have demonstrated St. Jude Medical FFR technology can improve patient outcomes and reduce medical costs in patients with stable coronary artery disease (CAD).

Now, in a study of 350 patients suffering NSTEMI heart attacks, St. Jude Medical PressureWireTM FFR measurement technology is credited with altering the treatment strategy of approximately 22 percent of patients. The study also demonstrated a trend toward a reduction in procedure-related myocardial infarction among patients whose therapy was guided by FFR using St. Jude Medical PressureWireTM technology.

"In patients suffering NSTEMI, traditiona diagnostic imaging tools have limited our ability to optimally assess which blockages require revascularization," said Dr. Colin Berry, a Professor of Cardiology and Imaging at the University of Glasgow and Principal Investigator of the FAMOUS-NSTEMI clinical trial. "What we've now found is fractional flow reserve technology has additive diagnostic and clinical benefits for NSTEMI patients. We need to continue to evaluate the technology's potential in new segments of patients."


The FAMOUS-NSTEMI trial is the first comprehensive clinical assessment of the ability of PressureWireTM FFR technology to guide treatment in patients suffering NSTEMI. Currently, physicians treating NSTEMI patients at a high risk for serious cardiac complications will often opt for a treatment strategy that relies on coronary angiography to assess blood flow within the arteries of the heart. FFR represents a new approach to managing NSTEMI patients because it relies less on subjective visual assessments of angiography and instead offers an objective physiological assessment of blood flow blockages.

"Using St. Jude Medical PressureWire, physicians can leverage FFR to better assess the need for interventional procedures and more accurately identify lesions that require stenting," said Dr. Mark Carlson, chief medical officer at St. Jude Medical. "The clinicians leading the FAMOUS-NSTEMI study have now confirmed that a new group of patients can benefit from FFR."

The FAMOUS-NSTEMI trial enrolled 350 patients in six U.K. hospitals between October 2011 and May 2013. Patients enrolled had at least one coronary stenosis at least 30 percent occluded at time of admission for NSTEMI. In patients randomized to the FFR-guided group, an FFR of greater than 0.80 indicated revascularization by PCI or coronary bypass surgery.

About the FAME Trials

The FAMOUS-NSTEMI study builds on data from the FAME and FAME 2 clinical trials, which support FFR as the standard of care for the treatment of patients with coronary artery disease (CAD).

The original FAME trial, which concluded in 2008, found FFR allows for more accurate identification of narrowed passages most likely to cause a coronary event, reducing rates of death, myocardial infarction (heart attack) and repeat revascularization.

Preliminary data from FAME 2 further supported FFR, and found FFR-guided PCI with PressureWireTM measurement technology is a cost-effective strategy that can improve clinical outcomes and quality of life in patients with stable coronary artery disease (CAD) over medical therapy alone. Results of both the FAME and FAME 2 trials were published in The New England Journal of Medicine.

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 (News - Alert) @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 (News - Alert), 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 28, 2013 and Quarterly Report on Form 10-Q for the fiscal quarter ended June 28, 2014. 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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