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

St. Jude Medical, Inc. STJ today announced it has received European CE Mark approval for its ILUMIEN™ system, the first integrated diagnostic technology that combines optical coherence tomography and fractional flow reserve 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 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.