Enrollment Completed in BIOFLOW-V Study of Biotronik's Orsiro Hybrid DES

April 19, 2016—Biotronik announced 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. The company is collaborating with Harvard Clinical Research Institute to conduct the trial.

BIOFLOW-V is an international, multicenter, prospective, randomized (2:1), controlled investigational device exemption trial. Patients with coronary artery disease were assigned to receive either Orsiro or another currently marketed DES. The primary endpoint is target lesion failure at 12 months after the index procedure.

The trial enrolled 1,334 patients at 91 sites in the United States, Canada, Europe, Israel, and the Asia Pacific region in less than a year. The company announced commencement of enrollment in the United States in June 2015. 

According to Biotronik, the Orsiro hybrid DES has demonstrated efficacy and safety in several clinical studies conducted outside the United States. In the BIOSCIENCE trial, the target lesion failure rate at 12 months was shown to be noninferior to the Xience stent family (Abbott Vascular).

Orsiro’s features include Biotronik’s ProBio passive coating and Biolute active coating. ProBio encapsulates the stent and minimizes interaction between the metallic surface and the surrounding tissue. The Biolute coating contains a bioabsorbable polymer that delivers a limus drug. 

The Orsiro hybrid DES was launched in Europe in 2011. It is limited to investigational use in the United States, advised Biotronik.

David Kandzari, MD, is the BIOFLOW-V United States Principal Investigator. In the company’s announcement, Dr. Kandzari commented, “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. Orsiro has already been the subject of several international clinical studies with positive results compared with conventional, permanent polymer DES. We look forward to evaluating the results of the technology in the United States setting for patients with coronary artery disease.” Dr. Kandzari is with Piedmont Heart and Vascular Institute in Atlanta, Georgia.