Prescient Medical, Inc. (Prescient), announced that it has received European CE Mark approval to commercialize its vProtect Luminal Shield Stent System. The device is approved for use in improving coronary artery luminal diameter in patients with symptomatic ischemic heart disease.
The novel vProtect Luminal Shield has the potential to change the way interventional cardiologists treat arterial plaques. The vProtect 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 positive 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 Luminal Shield in more specific patient groups, she concluded.