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BIOTRONIK Announces Completion of Patient Enrollment in BIOFLOW-IV Study Evaluating Safety and Efficacy of Orsiro

Vascular Intervention

(PresseBox) (Tokyo, Japan, ) BIOTRONIK, a leading manufacturer of cardio- and endovascular medical technology, announced today that patient enrollment for the BIOFLOW-IV study has been completed. The study is intended to support Japanese government approval of the Orsiro hybrid drug-eluting stent (DES), which 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's 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," commented one of the BIOFLOW-IV coordinating investigators, Dr. Shigeru Saito, Shonan Kamakura Hospital, Kanagawa, Japan.

Orsiro has already achieved excellent results in a number of European trials including BIOSCIENCE1, results of which were presented in a Hot Line session at the European Society of Cardiology (ESC) Congress in 2014 and published in the medical journal 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.

About Orsiro

The Orsiro hybrid drug-eluting stent (DES), launched in 2011, features the latest development in BIOTRONIK stent technology - 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. 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.

1 Pilgrim T et al. The Lancet. 2008, 384(9960).

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One of the world's leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce of more than 5,600 employees. Several million patients have received BIOTRONIK implants designed to save and improve the quality of their lives, or have been treated with BIOTRONIK coronary and peripheral vascular intervention products. Since its development of the first German pacemaker in 1963, BIOTRONIK has engineered many innovations, including BIOTRONIK Home Monitoring®; the world's first 4 F-compatible 200 mm peripheral stent; Orsiro, the industry's first hybrid drug-eluting stent; and the world's first implantable cardioverter defibrillators and heart failure therapy devices with ProMRI® technology.

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