vProtect Luminal Shield Stent System Wins EU Approval

Here’s a new device designed to improve coronary artery luminal diameter. The European Union just granted approval to Prescient Medical (Doylestown, Pennsylvania) to market its vProtect Luminal Shield catheter for treatment of coronary lesions in patients with symptomatic ischemic heart disease.

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.
The vProtect™ Luminal Shield recently completed phase 1 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.

Here’s Patricia Scheller, CEO of Prescient Medical discussing the approval of vProtect on FOX Business: