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

February 4, 2015—Biotronik announced the completion of patient enrollment for the BIOFLOW-IV study, which is intended to support Japanese government approval of the company’s Orsiro hybrid drug-eluting stent (DES). The device received European CE Mark approval in 2011.

BIOFLOW-IV is an international, multicenter, randomized, controlled study for patients with coronary artery disease treated with the Orsiro device compared with Abbott Vascular’s Xience Prime. The primary endpoint is target vessel failure at 1 year after enrollment. More than 40 clinical sites are participating in the study, noted the company.

Shigeru Saito, MD, one of the BIOFLOW-IV coordinating investigators, commented in Biotronik’s announcement, “With a thinner strut than conventional DES, Orsiro may have the advantage of being more rapidly covered by neointima. In addition, the unique ProBio passive coating on the surface of the stent has the potential to enhance its long-term safety.” Dr. Saito is from Shonan Kamakura Hospital in Kanagawa, Japan.

According to the company, Orsiro has achieved excellent results in a number of European trials including BIOSCIENCE, which was presented at the European Society of Cardiology’s ESC Congress 2014 in Barcelona, Spain, and published by Tomas Pilgrim, MD, et al in The Lancet (2014;384:2111–2122).

The study compared the Orsiro hybrid DES with Abbott’s Xience Prime using a primary endpoint of target lesion failure at 12 months. The large-scale, randomized, controlled, noninferiority study involved more than 2,000 patients from a real-world population. After 12 months, Orsiro met its study objective of noninferiority versus Xience Prime, hence performing as best in class and demonstrating its benefit in treating a large group of patients suffering from coronary artery disease.

The Orsiro device 
features the company’s hybrid solution that combines passive and active components. The ProBio passive coating encapsulates the stent and minimizes interaction between the metal stent and the surrounding tissue. The BioLute active coating contains a highly biocompatible polymer that delivers a limus drug via a bioabsorbable matrix. This hybrid coating is layered on top of the high performance Pro-Kinetic Energy stent platform with an advanced ultra-thin strut stent design and excellent deliverability, stated Biotronik.