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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 / Vascular Intervention

(PresseBox) (Buelach, Switzerland, ) 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.

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A global leader in cardio- and endovascular medical technology, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries. Several million patients have received BIOTRONIK implants designed to save and improve the quality of their lives, or have been treated with BIOTRONIK coronary and peripheral vascular intervention products. Since its development of the first German pacemaker in 1963, BIOTRONIK has engineered many innovations, including Magmaris, the first clinically-proven resorbable magnesium scaffold; BIOTRONIK Home Monitoring®; Pulsar-18, the world’s first 4F compatible stent for treating long lesions; Orsiro, the ultrathin 60 micron drug-eluting stent; and the world’s first implantable cardioverter defibrillators and heart failure therapy devices with ProMRI® technology.

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