Enrollment Begins in Biotronik's BIOVITESSE Trial
October 9, 2017—Biotronik announced the start of enrollment of the BIOVITESSE trial, a coronary stent trial to assess the safety and clinical performance of a new coronary stent in de novo coronary artery lesions. The polymer-free coronary stent combines the features of Biotronik's Pro-Kinetic Energy stent with a new antiproliferative limus drug designed to prevent excessive cell growth.
The BIOVITESSE prospective, multicenter, first-in-man trial will be conducted at five centers in Switzerland through August 2019. Primary endpoints are strut coverage at 1 month and in-stent late lumen loss at 9 months. Strut coverage will be assessed by optical coherence tomography analysis. Late lumen loss will be assessed by quantitative coronary angiography assessment.
The company advised that on September 28, the first implantations in the study were performed by Marco Moccetti, MD, at Cardiocentro Ticino in Lugano, Switzerland, and Lorenz Räber, MD, at University Hospital Bern in Bern, Switzerland.