vProtect Luminal Shield (TM) from Prescient Medical Receives CE Mark
DOYLESTOWN, Pa., Aug. 24 /PRNewswire/ — Medical device pioneer, Prescient Medical, Inc., announced today that it has received European CE Mark (Conformite Europeene) approval to commercialize its vProtect(TM) Luminal Shield Stent System. The device is now approved for use in improving coronary artery luminal diameter in patients with symptomatic ischemic heart disease.
The novel vProtect(TM) Luminal Shield has the potential to change the way interventional cardiologists treat arterial plaques. The vProtect(TM) Luminal Shield is designed to minimize arterial injury and its consequences, allowing the vessel to regain and maintain healthy physiological function. The device is a low radial force, thin-strut, self-expanding nitinol mesh, or “Shield” that is designed specifically for softer plaques.
“We are very pleased with the performance of the Shield in our clinical study program,” said principal investigator Juan F. Granada, MD, Medical Director, Skirball Center for Cardiovascular Research, Cardiovascular Research Foundation, New York, NY. “We achieved excellent technical results. In this clinical series there were no peri-procedural MACE events and we achieved device delivery success in all the cases. The Shield continues to demonstrate a very favorable efficacy profile in all cases evaluated to date.”
“This CE Mark approval represents a significant milestone for the company and reflects the positive results of our clinical studies to date,” noted Patricia Scheller, CEO of Prescient Medical. “It also marks the beginning of an exciting broad-based clinical program to assess the performance of the vProtect(TM) Luminal Shield in more specific patient groups,” she concluded.
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. The company is the recipient of the 2009 Frost and Sullivan Award for Product Innovation of the Year Award for vProtect(TM) Luminal Shield. For more information about Prescient Medical and its products, please visit our website at www.prescientmedical.com.
SOURCE Prescient Medical, Inc.