21.05.2014 – 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.”
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 bioabsorbable matrix. This hybrid coating is layered on top of the high performance PRO-Kinetic Energy stent platform, renowned for its advanced thin-strut stent design and exceptional deliverability.
As 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 5600 employees. Several million heart patients around the world 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 innovation – including BIOTRONIK Home Monitoring® in 2000, the world-s first 4F compatible 200mm peripheral stent, in 2010, Orsiro, the industry-s first hybrid drug-eluting stent, in 2011, and the world-s first implantable cardioverter-defibrillators and heart failure therapy devices with ProMRI® technology in 2012.
For more information, visit: www.biotronik.com
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