St. Jude Medical's Ilumien System Approved in Europe

July 14, 2011—St. Jude Medical, Inc. (St. Paul, MN) announced it has received European CE Mark approval for the Ilumien system, an integrated diagnostic technology that combines optical coherence tomography (OCT) and fractional flow reserve (FFR) technologies on one platform. The combined system provides physiological and anatomical information to improve the diagnosis and treatment of coronary artery disease, the company stated.

According to St. Jude Medical, the Ilumien system combines the company's PressureWire Aeris and the C7-XR OCT diagnostic imaging technology. It also incorporates St. Jude Medical's Wi-Box wireless device.

The PressureWire Aeris is a wireless interventional tool that measures FFR to evaluate the severity of blood flow blockages in the coronary arteries. The St. Jude Medical C7-XR OCT diagnostic imaging technology with Extreme Resolution intravascular imaging technology allows physicians to visualize and measure important vessel characteristics that are otherwise not visible or difficult to assess. In percutaneous coronary interventions, the two technologies help identify culprit lesions responsible for ischemia and provide physicians with precise measurements of lesion dimensions and vessel size and structure.

The Wi-Box enables the system to receive aortic pressure readings from the catheterization lab wirelessly. It provides a cable-free FFR solution, combining the ease of use of a built-in system with the cost efficiency of a mobile platform, the company stated.

“The Ilumien system provides me and my colleagues with an easy-to-use, flexible solution that combines OCT and FFR technology on one system,” commented Evelyn Regar, MD. “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.”