St. Jude Medical Receives European CE Mark Approval for its ILUMIEN System

St. Jude Medical has received European CE Mark approval for its ILUMIEN system, the first integrated diagnostic technology that combines optical coherence tomography (OCT) and fractional flow reserve (FFR) technologies on one platform for cardiac catheterizations.

FFR is an index determining the functional severity of narrowings in the coronary arteries by measuring pressure differences across stenoses. OCT utilizes near-infrared light to create images that help visualize and measure important vessel characteristics and stent positions. 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 C7x-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 patients’ heart muscle) and by providing physicians with precise measurements of lesion dimensions and vessel size and structure.

Additionally, the St. Jude Medical ILUMIEN system features the Wi-Box(TM), a wireless device that enables the ILUMIEN system to receive data (aortic pressure readings) from the catheterization lab wirelessly. The Wi-Box allows 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.

Press release: St. Jude Medical Announces European Approval of First and Only Combined FFR and OCT System…

Product page: ILUMIEN — Illuminating the Future of PCI Optimization…

Flashbacks: SJM Enhances Usability of Company’s FFR Measurement Technology; New Technology Reduces Risks After Cardiac Stenting Procedures; RADI and GE Healthcare Collaboration Delivers First Wireless FFR Monitoring