Complex Lesion BIOFLOW-III Subgroup Analyses Further Support Top Performance of BIOTRONIK Orsiro

BUELACH, Switzerland, May 22, 2014 – BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced new results from the subgroup analyses of the BIOFLOW-III registry at this year’s EuroPCR congress in Paris, France. The results were presented by investigator Dr. Jan van der Heijden, St. Antonius Hospital, Nieuwegein, Netherlands, and confirm earlier excellent safety and efficacy results for Orsiro.

BIOFLOW-III is an open-label clinical evaluation of Orsiro with Target Lesion Failure (TLF) rate at 12 months as the primary endpoint, enrolling 1,356 patients at 43 sites in 14 countries. Pre-specified sub-groups were diabetes, small vessel (≤2.75 mm), chronic total occlusion (CTO), and acute myocardial infarction (AMI). 743 subjects (55 percent) presented B2 or C type lesions, classified in accordance with ACC/AHA guidelines.

Preliminary data for this complex population demonstrated excellent device and procedure success (99.3 and 98.2 percent, respectively). Clinical data showed a low TLF rate of 5.1 percent and a definite and probable stent thrombosis rate of 0.5 percent up to the 12-month follow-up. This subgroup analysis demonstrated that the clinical performance of Orsiro is comparable to the overall cohort. “We are excited to have proven the excellent efficacy of the Orsiro stent in a complex patient population,” commented Dr. van der Heijden.

“At BIOTRONIK we are committed to enhancing physicians’ clinical effectiveness and ensuring the highest quality of medical procedures. Our unique coronary stent portfolio, featuring the Masterpieces Orsiro, PRO-Kinetic Energy, and PK Papyrus, represents a prominent example of our ambitions," commented Dr. Daniel Bühler, President BIOTRONIK Vascular Intervention.