FDA clears St. Jude's combined OCT, FFR system

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St. Jude Medical has received FDA clearance for its Ilumien system, a diagnostic technology that combines optical coherence tomography (OCT) and fractional flow reserve (FFR) technologies on one platform.

The combined system offers physicians physiological and anatomical insight for 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 St. Jude's C7-XR OCT diagnostic imaging technology with Extreme Resolution, an intravascular imaging technology that allows physicians to visualize and measure vessel characteristics. Combined, the two technologies may assist physicians in identifying culprit lesions responsible for ischemia, and also provide physicians with measurements of lesion dimensions, as well as vessel size and structure, according to the St. Paul, Minn.-based company.

St. Jude's Ilumien system features the Wi-Box, a device that enables the Ilumien system to receive wireless aortic pressure readings.

The Ilumien system was launched in Europe earlier this year.