Biotronik has announced that enrolment in its BIOFLOW-V clinical study has been completed. The company reports that 1,334 patients have been enrolled at 91 sites in the US, Canada, Europe, Israel, and the Asia Pacific region in under a year. The aim of the study is to provide further support of the safety and efficacy of the Orsiro hybrid drug-eluting stent system.
According to a press release, Biotronik is collaborating with Harvard Clinical Research Institute (HCRI) to conduct BIOFLOW-V—an international, multicentre, prospective, randomised (2:1), controlled investigational device exemption (IDE) trial. In the study, patients with coronary artery disease were assigned to receive either Orsiro or another currently marketed drug-eluting stent. The primary endpoint is target lesion failure at 12 months post–index procedure.
Principal investigator David Kandzari (Piedmont Heart and Vascular Institute, Atlanta, USA), says: “Enrolment in the BIOFLOW-V study was quickly completed because of physician interest in and enthusiasm for the clinical potential of Orsiro’s absorbable polymer combined with the excellent deliverability. Orsiro has already been the subject of several international clinical studies with positive results compared with conventional, permanent polymer drug-eluting stents. We look forward to evaluating the results of the technology in the US setting for patients with coronary artery disease.”
Already used in Europe, Orsiro has demonstrated efficacy and safety in several clinical studies conducted outside the US. In the BIOSCIENCE trial, the target lesion failure rate at 12-months was shown to be non-inferior to the Xience stent family.