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vProtect(TM) Luminal Shield Stabilizes Life-Threatening Plaque
Date:1/15/2009

Healthy Vessel Seen in 6-Month Follow-up Exam on First Patient to Receive Preventive Treatment for Vulnerable Plaque

ROTTERDAM, Netherlands and DOYLESTOWN, Pa., Jan. 15 /PRNewswire/ -- The first patient receiving focal preventive treatment for vulnerable plaque recently underwent a 6-month follow-up examination that revealed successful stabilization of the target plaque. The interventional cardiology team led by Professor Patrick W. Serruys, MD, PhD, of Erasmus University, placed a vProtect(TM) Luminal Shield in the left anterior descending (LAD) coronary artery of the patient at Erasmus Medical Center in Rotterdam in June of 2008. The 64-year-old man is enrolled in SECRITT I, a pilot study designed to evaluate the vProtect(TM) Luminal Shield as a treatment for vulnerable plaques--"silent" atherosclerotic deposits in the coronary arteries that do not produce symptoms until they rupture with potentially fatal consequences.

To date, the treated artery demonstrated excellent blood flow and healing. As part of the healing process the Shield is now covered by a thin layer of tissue, incorporating it into the arterial wall. This is a hallmark of a successful implant and demonstrated that the Shield performed much better than would be expected for traditional bare metal stents and comparable to the first generation of drug-eluting stents.

"The self-expanding vProtect(TM) Luminal Shield minimizes injury on deployment enabling safe placement over rupture-prone vulnerable plaques," said Patricia Scheller, CEO of Prescient Medical, the manufacturer of the vProtect(TM) Luminal Shield. "Given that there are more than 500,000 sudden cardiac deaths in the US, and more than 300,000 in Europe each year, we are pleased that our device addresses untreated vulnerable plaques, the culprit in a majority of sudden cardiac deaths."

Patients enrolled in SECRITT I have been referred to the cath lab for treatment of clinically significant coronary lesions, which are treated according to current standards of care. Using a combination of ultrasound and optical imaging techniques, the SECRITT I investigators examine the coronary arteries for signs of additional, non-flow-limiting vulnerable plaques, for which patients would not generally receive treatment. Patients with vulnerable plaques undergo follow-up diagnostic catheterizations 6 months post-treatment, at which time investigators determine the Shield's impact.

According to Professor Serruys, the vProtect(TM) Luminal Shield represents a logical extension of modern cardiac medicine: "We are very good at opening arteries that are blocked, but we have not succeeded in preventing heart attacks related to plaque rupture. The vProtect(TM) Luminal Shield has demonstrated that it can be safely placed over a vulnerable lesion without rupturing the plaque, and the results at six months are extremely promising. The Shield performed exactly as intended, allowing us to prevent plaque rupture and an acute event, rather than trying to repair the damage after the fact."

About Prescient Medical, Inc.

Prescient Medical, Inc. is a privately held medical device company dedicated to reducing deaths from heart attacks, the leading cause of death in much of the world. For more information, please visit our website at www.prescientmedical.com or call +1-866-376-0500.


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SOURCE Prescient Medical, Inc.
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