BIOTRONIK Announces First Enrollments to BIOVITESSE Trial
Clinical Study to Assess the Safety and Clinical Performance of a Coronary Stent System in De Novo Coronary Artery Lesions
BIOTRONIK has announced the start of enrollment of a coronary stent trial aiming at assessing the safety and clinical performance of a new coronary stent in de novo coronary artery lesions. On September 28, first Dr. Marco Moccetti, Cardiocentro Ticino, Lugano, Switzerland, and later on the same day Dr. Lorenz Raeber, University Hospital Bern, Switzerland, successfully implanted the new BIOTRONIK coronary stent in their first patients.
The polymer-free coronary stent combines the proven PRO-Kinetic Energy stent features with its ultrathin struts, with a new anti-proliferative limus drug designed to prevent excessive cell growth.
The BIOVITESSE prospective, multicenter, first-in-man trial will investigate the treatment of coronary de novo lesions. Primary endpoints are strut coverage at one month and in-stent late lumen loss (LLL) at nine months. Strut coverage will be assessed by optical coherence tomography (OCT) analysis. LLL will be assessed by quantitative coronary angiography (QCA) assessment.
“As an established and trusted provider of a leading vascular intervention portfolio, BIOTRONIK has once again demonstrated its commitment to innovation by the development of this new coronary stent system,” stated Dr. Daniel W. Buehler, BIOTRONIK President, Vascular Intervention. “Our BIOVITESSE stent system’s ease of use reflects our long-term expertise in developing coronary stents, which allows us to continue to improve performance and provide enhanced treatment options.”
The BIOVITESSE study will run in five centers in Switzerland until August 2019.
BIOTRONIK is a leading medical device company that has been developing trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries.