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Biotronik completes enrolment for new trial of Orsiro stent
Biotronik has announced the completion of enrolment for a new clinical study assessing the performance of its Orsiro hybrid drug-eluting stent (DES).
The BIOFLOW-V clinical trial attracted significant investigator interest, leading to a rapid enrolment process. A total of 1,334 patients were signed up across 91 sites in the US, Canada, Europe, Israel and the Asia Pacific region in less than a year.
Run in collaboration with the Harvard Clinical Research Institute, the study will examine rates of target lesion failure among patients with coronary artery disease, who have been assigned to receive treatment with either Orsiro or another currently marketed DES.
Results from the trial will be used to further support the safety and effectiveness of the system, which was originally launched in 2011 and is already widely used across Europe.
Marlou Janssen, president of Biotronik, said: "The unique technology of Orsiro DES has gained the respect of physicians and patients around the world who have access to it making it one of our most successful products globally."
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