FDA clears Ilumien system, the first and only combined FFR and OCT system


The Food and Drug Administration (FDA) has given clearance to St Jude Medical to market its Ilumien system. According to St Jude, this is 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 PressureWire Aeris (St Jude Medical), a wireless interventional tool that measures FFR to evaluate the severity of blood flow blockages in the coronary arteries, and the C7-XR OCT (St Jude Medical) diagnostic imaging technology with Extreme Resolution, a first-to-market intravascular imaging technology that allows physicians to visualise and measure important vessel characteristics otherwise not visible or difficult to assess with older intracoronary imaging technologies. Combined, the two technologies enable the optimisation of percutaneous coronary intervention (PCI) by assisting physicians in identifying culprit lesions responsible for ischaemia. 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 Joel Garcia, director of the cardiac catheterisation laboratory at the Denver Health Medical Center, USA. “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 system also features the Wi-Box, 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 C7-XR system with the C7 Dragonfly imaging catheter was launched in the USA in 2010 and the PressureWire Aeris was launched in the USA in 2009. The Ilumien system was launched in Europe earlier this year.