St. Jude Medical Announces FDA Clearance of First and Only Combined FFR and OCT System

ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced it has received U.S. Food and Drug Administration (FDA) clearance for its ILUMIEN™ system, the first integrated diagnostic technology that combines optical coherence tomography (OCT) and fractional flow reserve (FFR) technologies on one platform. The combined system offers physicians advanced physiological and anatomical insight to improve the diagnosis and treatment of coronary artery disease.

“By integrating FFR and OCT technologies, we are providing physicians with innovative technology that gives them the information they need to accurately diagnose and optimize therapy for their patients.”

The ILUMIEN system features the St. Jude Medical PressureWire™ Aeris, a wireless interventional tool that measures FFR to evaluate the severity of blood flow blockages in the coronary arteries, and the St. Jude Medical C7-XR™ OCT diagnostic imaging technology with Extreme Resolution™, a first-to-market intravascular imaging technology that allows physicians to visualize and measure important vessel characteristics otherwise not visible or difficult to assess with older intracoronary imaging technologies. Combined, the two technologies enable the optimization of percutaneous coronary intervention (PCI) by assisting physicians in identifying culprit lesions responsible for ischemia (coronary narrowings responsible for significantly obstructing the flow of blood to a patient’s heart muscle). The technologies also provide physicians with precise measurements of lesion dimensions, as well as vessel size and structure.

“The ILUMIEN system integrates two cutting-edge technologies on one platform,” said Dr. Joel Garcia, director of the cardiac catheterization laboratory at the Denver Health Medical Center. “The system offers physicians a simplified, streamlined option for the diagnosis and treatment of patients with culprit lesions that are in need of treatment strategies with advanced therapy guidance.”

The St. Jude Medical ILUMIEN system features the Wi-Box™, a wireless device that enables the ILUMIEN system to receive aortic pressure readings wirelessly. The Wi-Box provides physicians and staff a completely cable-free FFR solution, combining the ease of use of a built-in system with the cost efficiency of a mobile platform.

“The key to optimizing treatment of coronary artery disease is knowing which vessel needs treatment and how to treat it,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division. “By integrating FFR and OCT technologies, we are providing physicians with innovative technology that gives them the information they need to accurately diagnose and optimize therapy for their patients.”

The C7-XR System with the C7 Dragonfly™ Imaging Catheter was launched in the U.S. in 2010 and the PressureWire Aeris was launched in the U.S. in 2009. The ILUMIEN system was launched in Europe earlier this year.

About Fractional Flow Reserve (FFR)

Fractional Flow Reserve (FFR) is an index determining the functional severity of narrowings in the coronary arteries. 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.

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. In January 2009, St. Jude Medical announced results from the landmark FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) study, a randomized, prospective, multi-center study. The study enrolled 1,005 patients with multivessel coronary artery disease and 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. After two years, 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 Optical Coherence Tomography (OCT)

Optical Coherence Tomography (OCT) is a leading imaging technology platform that aids physicians in the diagnosis and treatment of cardiovascular disease. OCT utilizes near-infrared light to create images to visualize and measure important vessel characteristics otherwise not visible or difficult to assess with older intracoronary imaging technologies- such as fluoroscopy and intravascular ultrasound (IVUS). OCT can be especially important for the assessment of stent placement because the high-resolution images show precisely how the stent is holding the artery open and whether it is positioned correctly against the artery wall, optimizing treatment and follow-up strategies.

For more information, visit SJMILUMIEN.com.

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 Annual Report on Form 10-K for the fiscal year ended January 1, 2011 and Quarterly Report on Form 10-Q for the fiscal quarter ended July 2, 2011. 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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