Biotronik Completes Patient Enrollment in BIOFLOW-IV Study

Biotronik SE & Co. KG has completed patient enrollment for the BIOFLOW-IV study, designed to support Japanese government approval of the Orsiro hybrid drug-eluting stent (DES). The stent received CE mark in 2011.

BIOFLOW-IV is an international, multicenter, randomized, controlled study for patients with coronary artery disease in which more than 40 clinical sites are participating. The study compares Orsiro with Abbott Laboratories’ Xience Prime and has a primary endpoint of target vessel failure at one year post enrollment.

“With a thinner strut than conventional DES’s, 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,” said Shigeru Saito, M.D., of Shonan Kamakura Hospital in Kanagawa, Japan. He also is one of the
BIOFLOW-IV coordinating investigators.

Orsiro has already achieved excellent results in a number of European trials including Bioscience1, the results of which were published in The Lancet. Bioscience compared Orsiro with Abbott’s Xience Prime using a primary endpoint of target lesion failure (TLF) at 12 months.

The large-scale, randomized, controlled, non-inferiority BIOFLOW-IV study involved more than 2,000 patients from a real-world population. After 12 months, Orsiro met its study objective of non-inferiority 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 hybrid drug-eluting stent, launched in 2011, features a unique hybrid solution that combines passive and active components. proBIO passive coating encapsulates the stent and minimizes interaction between the metal stent and the surrounding tissue, according to the company. BIOlute active coating contains a highly biocompatible polymer that delivers a limus drug via a bio-absorbable matrix. This hybrid coating is layered on top of the high performance PRO-Kinetic Energy stent platform, renowned for its advanced ultra-thin strut stent design and outstanding deliverability.

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