News | October 26, 2011

Combined OCT-FFR System Cleared by FDA

 

October 26, 2011 – St. Jude Medical announced it has received U.S. Food and Drug Administration (FDA) clearance for its Ilumien system, 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 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 (PCI) by assisting physicians in identifying culprit lesions responsible for ischemia (coronary narrowings responsible for significantly obstructing the flow of blood to a patient’s heart muscle). The technologies also provide physicians with precise measurements of lesion dimensions, as well as vessel size and structure.

The St. Jude Medical Ilumien system 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 with 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 United States in 2010 and the PressureWireAeris was launched in the United States in 2009. The Ilumien system was launched in Europe earlier this year.

About Fractional Flow Reserve (FFR)

Fractional Flow Reserve (FFR) is an index determining the functional severity of narrowings in the coronary arteries. FFR specifically identifies which coronary narrowings are responsible for significantly obstructing the flow of blood to a patients' heart muscle (called ischemia), and it is used by the interventional cardiologist to direct coronary interventions and assess results for improved treatment outcomes.

Current data show that physiological assessment using FFR prior to placement of coronary stents helps physicians better optimize clinical outcomes by determining which specific lesion or lesions are responsible for a patient's ischemia.

About Optical Coherence Tomography (OCT)

Optical Coherence Tomography (OCT) is a leading imaging technology platform that aids physicians in the diagnosis and treatment of cardiovascular disease. OCT utilizes near-infrared light to create images to visualize and measure important vessel characteristics otherwise not visible or difficult to assess with older intracoronary imaging technologies- such as fluoroscopy and intravascular ultrasound (IVUS). OCT can be especially important for the assessment of stent placement because the high-resolution images show precisely how the stent is holding the artery open and whether it is positioned correctly against the artery wall, optimizing treatment and follow-up strategies.

For more information, visit www.SJMILUMIEN.com

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