Biotronik Japan Enrolls First Patients in Bioflow-IV Clinical Study

Biotronik Japan has enrolled the first patient in its Bioflow-IV study, which aims to verify the efficacy and safety of the Orsiro Hybrid Drug-Eluting stent.

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

Coordinating investigator of the Bioflow-IV study, Shigeru Saito, M.D., director of the Cardiology and Catheterization laboratories and vice president of Shonan Kamakura Hospital, Kanagawa, Japan, implanted the first stent in the study. “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,” he said.

Efficacy and safety of Orsiro as demonstrated by the Bioflow-I, – II, and -III studies:

In the Bioflow-I first in-man study, late lumen loss, which was the primary endpoint, was 0.05±0.22 mm at nine months.

Bioflow-II was a prospective, noninferiority randomized controlled study comparing Orsiro with Xience Prime. The primary endpoint in-stent late lumen loss at nine months verified non-inferiority, which was confirmed with 0.10±0.32 mm vs. 0.11±0.29 mm, respectively. There also was no significant difference in target lesion failure (TLF) at nine months, which was 4.8 percent in the Orsiro arm vs. 5.3 percent in the Xience arm.

As a prospective, all-comers, multi-center registry, the BIOFLOW-III’s primary endpoint demonstrated 4.7 percent of TLF at 12 months.

Orsiro received CE mark in 2011 and is the latest development in Biotronik stent technology: a hybrid solution that combines passive and active components. Probio passive coating encapsulates the stent and minimizes interaction between the metal and the surrounding tissue. 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 bare metal stent platform, renowned for its advanced thin-strut stent design and outstanding deliverability.

Biotronik is headquartered in Berlin, Germany, and has a global workforce of more than 5,600 employees. Its U.S. headquarters is located in Lake Oswego, Ore.