Biotronik said yesterday that it began enrolling patients in a trial designed to assess the safety and efficacy of a new coronary drug-eluting stent in de novo coronary artery lesions.
The Biovitesse polymer-free device combines ultra-thin struts with a new anti-proliferative limus drug designed to stop excessive cell growth, the company reported.
In September, Dr. Marco Moccetti at Cardiocentro Ticino and Dr. Lorenz Raeber at the University Hospital Bern implanted the new coronary stent in their first patients.
The first-in-man trial includes primary endpoints of strut coverage at one month and in-stent late lumen loss at nine months.
“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,” president of Biotronik’s vascular intervention business, Daniel Buehler, said in prepared remarks.
“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 study is slated to run in Switzerland until Aug. 2019.