January 15, 2009 - The six-month follow-up examination of a 64-year-old man enrolled in SECRITT I, a pilot study designed to evaluate the vProtect Luminal Shield as a treatment for vulnerable plaque, revealed that the target plaque was successfully stabilized.
The interventional cardiology team led by Professor Patrick W. Serruys, M.D., PhD, of Erasmus University, placed the vProtect Luminal Shield in the left anterior descending (LAD) coronary artery of the patient at Erasmus Medical Center in Rotterdam in June of 2008.
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 reportedly 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.
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 six months post-treatment, at which time investigators determine the Shield's impact.
"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 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," said Dr. Serruys.
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