St. Jude Medical Inc. (NYSE:STJ) got the FDA’s green light for the U.S. market’s first combined FFR/OCT blood vessel imaging system for diagnosis and treatment of coronary artery disease.
The Ilumien system combines St. Jude’s PressureWire Aeris wireless fractional flow reserve imaging technology, which allows physicians to visualize blood vessel characteristics, and its Extreme Resolution optical coherence tomography, which helps evaluate the severity of blood flow blockages in coronary arteries.
Together they can help physicians identify culprit blood vessel lesions responsible for ischemia, the narrowing of arteries that can result in reduced blood flow to heart muscles.
"The key to optimizing treatment of coronary artery disease is knowing which vessel needs treatment and how to treat it," cardiovascular division president Frank Callaghan said in prepared remarks. "By integrating FFR and OCT technologies, we are providing physicians with innovative technology that gives them the information they need to accurately diagnose and optimize therapy for their patients."
The Ilumien system won CE Mark approval in the European Union in July.
St. Jude CEO Daniel Starks made waves last week when he flamed cross-town rival Medtronic (NYSE:MDT) during a conference call with analysts.
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