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St. Jude Medical Announces European Approval of First and Only Combined FFR and OCT System

Date Announced: 14 Jul 2011

ILUMIEN system assists physicians in optimizing percutaneous coronary interventions.

ST. PAUL, Minn.--(BUSINESS WIRE)-- St. Jude Medical, Inc. (NYSE:STJ - News), a global medical device company, today announced it has received European CE Mark approval 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.

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 patients' heart muscle) and by providing physicians with precise measurements of lesion dimensions and vessel size and structure.

“The ILUMIEN system provides me and my colleagues with an easy-to-use, flexible solution that combines OCT and FFR technology on one system,” said Dr. Evelyn Regar, M.D., Ph.D., FESC, Associate Professor, Department of Interventional Cardiology Thoraxcenter in Rotterdam, Netherlands. “Having these two cutting edge technologies together is a welcome advancement for therapy guidance, allowing me to choose the right tools for each patient situation.”

Additionally, the St. Jude Medical ILUMIEN system features the Wi-Box™, a wireless device that enables the ILUMIEN system to receive data (aortic pressure readings) from the catheterization lab wirelessly. The Wi-Box allows 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.

“Knowing which lesion to treat and how to treat it is the key to optimizing interventional treatment strategies,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division. “We believe integrating these technologies is key to providing physicians a simplified, streamlined option for the diagnosis and treatment of patients with coronary artery disease.”

The C7-XR System with the C7 Dragonfly™ Imaging Catheter and the PressureWire Aeris were launched in Europe in 2009.

Source: St Jude Medical

Contact

Kate Stoltenberg
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E-mail: kstoltenberg@sjm.com

Web Site: www.sjm.com

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