BIOTRONIK Japan Announces First Patients Enrolled in BIOFLOW-IV Clinical Study

TOKYO, Japan, October 24, 2013 – BIOTRONIK Japan has announced enrollment of the first patient in the BIOFLOW-IV study, which aims to verify the efficacy and safety of the Orsiro Hybrid Drug-Eluting Stent (DES) from BIOTRONIK. The high quality and efficacy of Orsiro has already been confirmed by three important trials, BIOFLOW-I, -II, and –III, which demonstrated the safety and efficacy of Orsiro.

The BIOFLOW-IV study is the first prospective, randomized, controlled, global study to compare the target vessel failure (TVF) rate of Orsiro DES and Abbott’s Xience Prime/Xpedition DES in a non-inferiority setting. 12 sites in Japan and 29 sites in the EU are participating in the multi-center study with the primary endpoint of TVF at 12 months.

Coordinating investigator of the BIOFLOW-IV study, Dr. Shigeru Saito, MD, Director of the Cardiology and Catheterization Laboratories and Vice President of Shonan Kamakura Hospital, Kanagawa, Japan, implanted the first stent in the study. He commented, “Orsiro has excellent deliverability and obviously thinner struts by IVUS observation than the current available DESs in Japan, which would be associated with earlier neointimal coverage after Orsiro implantation.”