FDAnews Device Daily Bulletin
Medical Devices / Research and Development

Medinol Completes Enrollment of Coronary Stent System Trial

Sept. 24, 2015
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Israel-based cardiology devicemaker Medinol has completed enrollment in its Bionics clinical trial designed to evaluate the safety and effectiveness of a eDES coronary stent system.

The company has enrolled 1,918 patients in the U.S., EU, Canada and Israel. The results will be submitted to the FDA for approval to treat patients with narrowing or blockage of their coronary arteries.

The primary endpoint of the study is target lesion failure as determined at 12 months, according to Medinol.

The stent system is coated with an elastomer designed to prevent the cracking or peeling that may occur with brittle polymers used in other DES during the crimping and deployment processes. — Michael Cipriano