ST. PAUL, Minn., St. Jude Medical, Inc., a global medical device company, today announced it has received U.S. Food and Drug Administration (FDA) clearance for its ILUMIEN(TM) 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(TM) 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(TM) OCT diagnostic imaging technology with Extreme Resolution(TM), a first-to-market intravascular imaging technology that allows physicians to visualize and measureimportant 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(TM), 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(TM) 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.