Enrollment Complete in BIOTRONIK's BIOFLOW-V Clinical Study

Vascular Intervention

Lake Oswego, Oregon / Buelach, Switzerland, (PresseBox) - BIOTRONIK, a global leader in cardio- and endovascular medical technology, announced today that enrollment is complete in the BIOFLOW-V clinical trial. Results will be used to further support the safety and effectiveness of BIOTRONIK’s Orsiro hybrid drug-eluting stent (DES) system.

Investigator interest in Orsiro’s innovative technology led to a rapid enrollment process with 1,334 patients enrolled at 91 sites in the US, Canada, Europe, Israel, and the Asia Pacific region in under a year.

BIOTRONIK is collaborating with Harvard Clinical Research Institute (HCRI) to conduct BIOFLOW-V: an international, multi-center, prospective, randomized (2:1), controlled investigational device exemption (IDE) trial. Patients with coronary artery disease were assigned to receive either Orsiro or another currently marketed DES. The primary endpoint is target lesion failure (TLF) at 12 months post–index procedure[1].

“Enrollment in the BIOFLOW-V study was quickly completed because of physician interest in and enthusiasm for the clinical potential of Orsiro’s absorbable polymer combined with the excellent deliverability,” commented BIOFLOW-V US principal investigator Dr. David Kandzari, Piedmont Heart and Vascular Institute, Atlanta, Georgia. ”Orsiro has already been the subject of several international clinical studies with positive results compared with conventional, permanent polymer drug-eluting stents. We look forward to evaluating the results of the technology in the US setting for patients with coronary artery disease.”

Already widely used in Europe, Orsiro has demonstrated efficacy and safety in several clinical studies conducted outside the US. In the BIOSCIENCE trial[2], the TLF rate at 12-months was shown to be non-inferior to the Xience stent family.

“The unique technology of Orsiro DES has gained the respect of physicians and patients around the world who have access to it making it one of our most successful products globally,” said Marlou Janssen, President BIOTRONIK, Inc. “Its medical benefits are demonstrated by a magnitude of clinical evidence in large investigator-initiated trials.”

More information on the BIOFLOW-V study is available at www.clinicaltrials.gov, identifier: NCT02389946.

About Orsiro

The Orsiro hybrid drug-eluting stent (DES), launched in 2011, features state-of-the-art BIOTRONIK stent technology – a unique hybrid solution that combines passive and active components. ProBIO passive coating encapsulates the stent and minimizes interaction between the metallic surface and the surrounding tissue. BIOlute active coating contains a unique bioabsorbable polymer that delivers a limus drug.

* CAUTION – Investigational device. Limited by United States law to investigational use. 


[1] Target lesion failure is defined as a composite of all cardiac death, target vessel Q-wave or non–Q-wave myocardial infarction (MI), or clinically-driven target lesion revascularization.

[2] Pilgrim T et al. The Lancet. 2014; 384(9960): 2111-22 

For more information, visit: www.biotronik.com

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A global leader in cardio- and endovascular medical technology, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries. 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®; Pulsar, the world's first 4 F compatible stent for treating long lesions; 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.

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