Complex Lesion BIOFLOW-III Subgroup Analyses Further Support Top Performance Of BIOTRONIK SE & Co.KG 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.

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.

About BIOTRONIK

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 innovations – 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

Contact:

Manuela Schildwächter
Senior Manager Communications & PR
BIOTRONIK SE & Co. KG
Woermannkehre 1
12359 Berlin, Germany
Tel. +49 (0) 30 68905 1414
Email: presse@biotronik.com

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