FDA Clears St. Jude's Ilumien System

October 26, 2011—St. Jude Medical, Inc. (St. Paul, MN) announced that it has received US Food and Drug Administration (FDA) clearance for its Ilumien system. The Ilumien system is an integrated diagnostic technology that combines optical coherence tomography (OCT) and fractional flow reserve (FFR) technologies on one platform to provide advanced physiological and anatomical insight to improve the diagnosis and treatment of coronary artery disease.

According to the company, 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. Additionally, the Ilumien incorporates the St. Jude Medical C7-XR OCT diagnostic imaging technology with Extreme Resolution that allows visualization and measurement of important vessel characteristics otherwise not visible or difficult to assess with older intracoronary imaging technologies.

St. Jude Medical stated that the two technologies combine to optimize percutaneous coronary intervention by assisting physicians in identifying culprit lesions responsible for ischemia and by providing physicians with precise measurements of lesion dimensions, as well as vessel size and structure. The Ilumien system also features the Wi-Box, a wireless device that enables the system to receive aortic pressure reading.

“The Ilumien system integrates two cutting-edge technologies on one platform,” commented Joel Garcia, MD. “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 company advised that the Ilumien system was launched in Europe earlier this year. In the United States, St. Jude launched the C7-XR system with the C7 Dragonfly imaging catheter in 2010 and the PressureWire Aeris in 2009.