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St. Jude Medical’s novel heart disease diagnostic tool cleared in Europe

St. Jude has received European regulatory clearance for a diagnostic tool for treating heart disease.

St. Jude Medical (NYSE:STJ) announced Thursday that it has received European regulatory clearance for its Ilumien system, a diagnostic tool for treating heart disease.

The Minnesota maker of new innovative medical devices said the system is the world’s first and only diagnostic tool that integrates optical coherence tomography (OCT) and fractional flow reserve (FFR) technologies on one platform.

FFR is a guide wire-based procedure that can accurately measure blood pressure and flow through a specific part of the coronary artery. OCT provides noninvasive cross-sectional imaging of biological tissue.

St. Jude’s Ilumien system has the St. Jude Medical PressureWire Aeris, a wireless interventional tool that measures FFR to evaluate how bad the blockage is in coronary arteries preventing blood flow. It also comprises the C7-XR OCT diagnostic imaging technology with Extreme Resolution, a novel intravascular imaging technology that allows physicians to see and measure vessel characteristics either invisible or difficult to assess using older imaging technology.

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Combined, the two technologies help to optimize percutaneous coronary intervention (PCI) by increasing a doctor’s ability to identify lesions responsible for causing ischemia and in providing accurate measurements.

The Ilumien system also has a wireless device that enables it to receive aortic pressure readings from the catheterization lab.

“Knowing which lesion to treat and how to treat it is the key to optimizing interventional treatment strategies,” said Frank Callaghan, president of the the company’s cardiovascular division, in a statement. “We believe integrating these technologies is key to providing physicians a simplified, streamlined option for the diagnosis and treatment of patients with coronary artery disease.”

St. Jude’s cardiovascular division garnered $327 million in the first quarter, up 28 percent over the first quarter of 2010, including $6 million of favorable foreign currency translations.