July 27, 2009 – Prescient Medical Inc. received the prestigious 2009 North American Product Innovation of the Year Award from Frost & Sullivan for Atherosclerosis Lesion Management, for its efforts to reduce deaths related to heart attacks using the vProtect Luminal Shield.
Heart attacks are now widely believed to occur when so-called "vulnerable plaque” ruptures, releasing cholesterol and cellular debris into the blood stream and potentially causing a clot that disrupts blood flow to the heart. The vProtect Luminal Shield is a self-expanding nitinol device designed to treat soft, recently ruptured and at-risk lesions in coronary arteries. Clinical evaluation of the Shield, which has not yet received marketing approval, is proceeding rapidly.
"This unique catheter-based, guidewire-deliverable device supports the body's natural healing process and promotes growth of endothelial cells over the lesion's thin fibrous cap to prevent it from rupturing," explained Bhavatharini Rajesh, research analyst, Frost & Sullivan.
The vProtect Luminal Shield recently completed phase I first-in-human trials for the treatment of de novo obstructive coronary lesions. The Shield is also being evaluated in an investigator-sponsored study known as the SECRITT I (Santorini Criteria for Investigating and Treating Thin Capped Fibroatheroma) trial for the treatment of vulnerable plaques, and a separate study is planned to evaluate use of the Shield in patients with acute coronary syndromes (ACS).
A second Prescient Medical product, the vPredict Optical Catheter System, is being developed for the detection of vulnerable plaque. It will be evaluated in tandem with the vProtect Luminal Shield in the PRESCIENT (Predictive use of Spectroscopic tissue Classification In Evaluating a Novel Treatment) trial, an ambitious study designed to evaluate the detection and prophylactic treatment of vulnerable plaques.
“The vProtect Luminal Shield should revolutionize the management of atherosclerotic lesions and prove to be a boon for interventional cardiologists and, most importantly, for patients by improving their quality of life and outcome," Rajesh said.
Previous Frost & Sullivan award recipients include Boston Scientific for the 2008 United States Coronary Stent Market Leadership Award and Bristol-Myers Squibb for the 2008 United States Breast Cancer Therapeutics Product Innovation of the Year Award.
For more information: www.prescientmedical.com