March 5, 2009 - Prescient Medical Inc. announced it completed enrollment in February of 30 patients in the first phase of its first-in-human clinical trial for the vProtect Luminal Shield, conducted at the Corbic Research Institute in Colombia.
The vProtect Luminal Shield is a self-expanding intracoronary prosthesis designed to limit arterial injury that typically occurs when stents are deployed.
The Shield successfully crossed all target lesions and was safely implanted in all 30 patients, boasting a technical success rate of 100 percent. Moreover, no procedural or in-hospital complications were reported for any of the patients. The patients enrolled in the study had non-calcified lesions in coronary arteries, lesions that would normally be treated with traditional balloon-expandable stents.
No major adverse coronary events (MACE) were reported at 30 days post-implant in the 28 patients who had reached that milestone. Nine-month angiographic follow-up was reported for two initial patients; there was no evidence of significant neointimal growth in these patients.
"We are very pleased with the performance of the Shield in this preliminary study. We have achieved an excellent technical result, and soon we will know more about clinical outcomes with the Shield," said co-principal investigator Juan A. Delgado, M.D. of Corbic Research Institute.
A new study evaluates use of the vProtect Luminal Shield in non-obstructive "vulnerable plaque" lesions that may rupture and cause acute myocardial infarction. According to Dr. Delgado, "The self-expanding Shield is designed to deploy with less injury to the artery, which should reduce neointimal overgrowth compared with currently marketed bare metal stents. We think these properties make the Shield a promising treatment to stabilize vulnerable plaque and prevent major events like heart attacks."
For more information: www.prescientmedical.com