LAKE OSWEGO, Oregon, and BUELACH, Switzerland, April 19, 2016 -BIOTRONIK, a global leader in cardio- and endovascular medical technology, announced today that enrollment is complete in the BIOFLOW-V clinical trial. Results will be used to further support the safety and effectiveness of BIOTRONIK’s Orsiro hybrid drug-eluting stent (DES) system.
Investigator interest in Orsiro’s innovative technology led to a rapid enrollment process with 1,334 patients enrolled at 91 sites in the US, Canada, Europe, Israel, and the Asia Pacific region in less than a year.
BIOTRONIK is collaborating with Harvard Clinical Research Institute (HCRI) to conduct BIOFLOW-V: an international, multi-center, prospective, randomized (2:1), controlled investigational device exemption (IDE) trial. Patients with coronary artery disease were assigned to receive either Orsiro or another currently marketed DES. The primary endpoint is target lesion failure (TLF) at 12 months post index procedure.1
“Enrollment 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,” commented BIOFLOW-V US principal investigator Dr. David Kandzari, Piedmont Heart and Vascular Institute, Atlanta, Georgia. ”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 widely used in Europe, Orsiro has demonstrated efficacy and safety in several clinical studies conducted outside the US. In the BIOSCIENCE trial,2 the TLF rate at 12-months was shown to be non-inferior to the Xience stent family.
“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,” said Marlou Janssen, President BIOTRONIK, Inc. “Its medical benefits are demonstrated by a magnitude of clinical evidence in large investigator-initiated trials.”
More information on the BIOFLOW-V study is available at www.clinicaltrials.gov, identifier: NCT02389946.
* CAUTION – Investigational device. Limited by United States law to investigational use.
1. Target lesion failure is defined as a composite of all cardiac death, target vessel Q-wave or
non–Q-wave myocardial infarction (MI), or clinically-driven target lesion revascularization.
2. Pilgrim T et al. The Lancet. 2014; 384(9960): 2111-22