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news.Prescient Medical, a medical device company, has reached a crucial milestone by completing the enrollment 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.
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According to the company, the shield successfully crossed all target lesions and was safely implanted in all 30 patients, with a technical success rate of 100%. 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 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, the company said.
Juan Delgado, co-principal investigator, said: “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.”