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Patient Receives vProtect(TM) Luminal Shield in First-Ever Vulnerable Plaque Clinical Trial
Date:6/30/2008

Prescient Medical - SECRITT I Study to Evaluate Preventive Treatment of

Potentially Life Threatening Vulnerable Plaques

ROTTERDAM, Netherlands and DOYLESTOWN, Pa., June 30 /PRNewswire/ -- An interventional cardiology team led by Professor Patrick W. Serruys successfully placed a vProtect(TM) Luminal Shield in the left anterior descending (LAD) coronary artery of a 64-year-old man at Erasmus Medical Center in Rotterdam. This case marks the start of a pilot study, known as SECRITT I, designed to evaluate the vProtect(TM) Luminal Shield as a treatment for vulnerable plaques -- atherosclerotic deposits in the coronary arteries that do not produce symptoms until they rupture with potentially fatal consequences. There are more than 500,000 sudden cardiac deaths in the US, and more than 300,000 in Europe, every year. The sudden and unexpected passing of Tim Russert, host of NBC's Meet the Press, is thought to have been the result of a vulnerable plaque rupture.

The SECRITT investigators plan to place the self-expanding vProtect(TM) Luminal Shield in 15 patients with plaques identified as vulnerable by a combination of ultrasound and optical imaging techniques. These patients will be matched with 15 controls-patients who also have non-blood-flow-limiting plaques or "lesions" that have been identified as vulnerable-who will not receive the Shield. All patients are elective patients that have been referred to the cathlab for the treatment of a major lesion impairing normal cardiac function. All 30 patients will undergo follow-up diagnostic catheterizations 6 months after the initial treatment visit, at which time their lesions will be re-evaluated. This information will enable the investigators to observe whether the Shield has stabilized the target lesions.

According to Professor Patrick W. Serruys, MD, PhD, of Erasmus University, the SECRITT I trial represents the logical extension of modern cardiac medicine: "We are very good at op
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