Small Vessel BIOFLOW-II Subgroup Analyses Demonstrate Top Performance of BIOTRONIK Orsiro

BUELACH, Switzerland, May 21, 2014 – BIOTRONIK, a leading manufacturer of cardiovascular medical technology, announced new results from the subgroup analyses of the BIOFLOW-II clinical trial at this year’s EuroPCR congress in Paris, France. The results were presented by investigator Dr. Manel Sabaté, Hospital Clínico y Provincial de Barcelona, Barcelona, Spain. The study confirms earlier excellent safety and efficacy results for Orsiro.

BIOFLOW-II is a prospective, international, multi-center, randomized trial evaluating the safety and efficacy of Orsiro against Xience Prime with the primary endpoint of in-stent late lumen loss at nine months and a total of 452 patients enrolled. The one-year subgroup study results focused on the small vessel cohort, accounting for 57.3 percent (Orsiro n=168/298, Xience n=91/154) of all patients, and the diabetic subgroup, accounting for 28.3 percent (Orsiro n=84/298, Xience n=44/154) of all patients.

Clinical follow-up visits are performed at 1, 6 and 12 months, and annually for 5 years post-procedure. The Target Lesion Failure (TLF) rate in the small vessel cohort at 12 months was numerically lower in the Orsiro group at 7.4 percent compared to 12.3 percent with Xience (p=0.2065). No statistical significance was observed in TLF rate in the diabetic cohort at 12 months, with 6.0 percent in the Orsiro group and 4.5 percent in the Xience group (p=0.7201).

“The results of the BIOFLOW-II trial demonstrate the comparable performance of Orsiro and Xience Prime in the treatment of these classic challenging populations,” commented Dr. Sabaté during his presentation. “The lower Target Lesion Failure rate in the small vessel cohort at 12 months may be a first indicator that Orsiro should be the primary option for PCI in small vessels.”

“Around the world, interventional cardiologists and their teams trust our top-performing stent family in several areas of coronary therapy,” commented Dr. Alexander Uhl, Vice President of Marketing, BIOTRONIK Vascular Intervention. “Demonstrating excellent clinical results enforces our strong commitment to developing best-in-class products like our Masterpieces Orsiro, PRO-Kinetic Energy and PK Papyrus.”