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news.Nexeon MedSystems, a developer of medical technology for the treatment of cardiovascular disease, has initiated Protex I, a first-in-man trial designed to evaluate the safety of the prohealing Protex coronary stent system for the treatment of coronary artery disease.
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The trial, called Protex I, will enroll 50 patients at five sites in Europe. Follow-up examinations will be performed at 30 days, six months and nine months. The six-month follow-up examination will evaluate both neointimal volume by intravascular ultrasound and percent binary restenosis by angiography.
William Wijns, managing director of the cardiovascular center Aalst in Belgium, will serve as the principal investigator of the clinical trial. The Protex system integrates Nexeon’s unique low-profile (0.86mm) cobalt alloy stent platform with SurModics’s Finale prohealing extracellular matrix coating.
Mark Bates, CEO and founder of Nexeon, said: “The enrollment of the first patient in Nexeon’s initial clinical trial marks a significant milestone for the company and is the culmination of many years work from talented clinicians, engineers and scientists.”