Data Presented on Orsiro Hybrid Drug – El uting Stent at EuroPCR 2015 Highlights Safety and Efficacy in High – Risk Patients

Experts at BIOTRONIK-Sponsored Symposium Discussed Orsiro’s Performance in Difficult Cases as well as Coming Developments in Percutaneous Coronary Intervention

PARIS, France, May 20, 2015—BIOTRONIK, a leading manufacturer of cardio- and endovascular medical technology, today hosted a scientific symposium regarding Orsiro, the industry’s first hybrid Drug-Eluting Stent (DES). During the symposium at EuroPCR, experts emphasized a series of studies which have demonstrated Orsiro’s efficacious performance in the treatment of discrete de-novo stenotic lesions and in-stent restenotic lesions as best-in-class for high-risk patient subgroups.

Dr. Juan F. Iglesias, Lausanne University Hospital (CHUV), Switzerland, discussed promising results from an ad hoc analysis of the BIOSCIENCE trial, the largest published investigator-initiated trial evaluating the safety and efficacy of Orsiro to date; the results of the multi-center, randomized, controlled all-comers non-inferiority study were first published in The Lancet. A sub-group of 407 patients suffering from acute ST-segment elevation myocardial infarction (STEMI) revealed that patients with this potentially fatal condition benefited from treatment with Orsiro, a sirolimus-eluting stent with a bioabsorbable polymer, in comparison to an everolimus-eluting stent with a durable polymer (DP-EES). At one year, the primary endpoint Target Lesion Failure (TLF) occurred in seven (3.4 percent) patients treated with Orsiro and 17 (8.8 percent) patients treated with DP-EES.

Additionally, new three-year data from the BIOFLOW-II randomized controlled trial was presented. BIOFLOW-II was a prospective, international, multi-center, randomized trial evaluating the safety and efficacy of Orsiro compared with Xience Prime. These positive long-term results demonstrated Orsiro’s long-term healing properties following treatment of patients with coronary artery disease or high risk disease.

“Further analysis of the high-risk subgroups in the BIOFLOW and BIOSCIENCE trials reveals Orsiro’s effectiveness in treating challenging cases,” stated lead investigator of the BIOSCIENCE trial Dr. Thomas Pilgrim, University of Bern, Switzerland. “Orsiro’s noted benefit for STEMI patients in particular is worth further examination in a randomized trial.”

In addition to Dr. Iglesias’s presentation on Orsiro, the BIOTRONIK symposium also focused on current and future developments in coronary intervention. Dr. Michael Joner, CVPath, Washington DC, USA, described preclinical work comparing bioabsorbable to permanent polymer DES, addressing the biocompatibility and healing aspects of these technologies. Dr. Pilgrim examined the current controversy regarding dual antiplatelet therapy (DAPT) in combination with bioabsorbable polymer DES implantation. Finally, Dr. Michael Haude, Lukaskrankenhaus, Neuss, Germany, discussed the ongoing BIOSOLVE-II clinical trial, which will establish the safety and performance of BIOTRONIK’s drug-eluting absorbable magnesium-based scaffold.*

“Our mission is to save lives and improve quality of life for patients. We achieve this not only with our innovative products like Orsiro, but also by facilitating the exchange of knowledge and expertise among leaders in the field of vascular intervention,” commented Dr. Alexander Uhl, Vice President of Marketing, BIOTRONIK Vascular Intervention. “The excellent calibre of our partners in the medical and scientific community enables us to contribute meaningfully to the debate and develop devices of the highest
quality and safety.”

About BIOTRONIK
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 5,800 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 200mm 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.

*Not available for sale.

For more information, visit: www.biotronik.com

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

Comments are closed.