BIOTRONIK Announces First US Patient Enrolled in the BIOFLOW-V Clinical Study

LAKE OSWEGO, Oregon, June 18, 2015 - BIOTRONIK, a leading manufacturer of cardio- and endovascular medical technology, announced today that the first US patient has been enrolled in the BIOFLOW-V clinical study. Results will be used to further demonstrate the safety and effectiveness of BIOTRONIK’s Orsiro hybrid drug-eluting stent (DES). The first US implant was successfully performed by Dr. David Trice at Thomas Hospital in Fairhope, Alabama.

BIOTRONIK is collaborating with Harvard Clinical Research Institute (HCRI) to conduct BIOFLOW-V. The study is a prospective, international, multi-center, randomized, controlled investigational device exemption (IDE) trial. The primary endpoint is target lesion failure (TLF) at 12 months post–index procedure¹. The study is planned to enroll 1,334 prospective patients at up to 150 sites in the United States, Canada, Europe, Israel and the Asia Pacific region.

Eligible patients with coronary artery disease (CAD) will be randomized in a 2:1 ratio to receive either Orsiro or another currently marketed DES.

Already widely used in Europe, Orsiro has consistently demonstrated efficacy and safety in study results. The BIOSCIENCE trial, recently published in The Lancet², provides results which show Orsiro to be non-inferior compared to the Xience stent family in a patient population reflective of routine clinical practice. Orsiro also demonstrated angiographic and clinical non-inferiority to Xience Prime in BIOFLOW-II³, a prospective, international, multi-center, randomized trial, which evaluated the safety and efficacy of Orsiro. Subgroup analyses of BIOFLOW-II and BIOFLOW-III⁴, an all-comers registry, also demonstrated low restenosis rates in small vessels and complex B2/C lesions.

More recently, the latest one year data from the industry-independent SORT OUT VII trial presented at EuroPCR 2015 revealed Orsiro to be non-inferior to the Nobori stent in a large, all-comers population⁵. In that trial, Orsiro demonstrated enhanced safety and a three-times reduced risk of stent thrombosis.

“Based on the encouraging previous study results, I am very excited that enrollment in the BIOFLOW-V study has started and BIOTRONIK can begin the process of bringing this remarkable product to US patients,” commented BIOFLOW-V US principal investigator Dr. David Kandzari, Piedmont Heart Institute, Atlanta, Georgia. “As a treatment option, I have no doubt Orsiro will benefit both patients and physicians in the US as it has for the past four years in Europe.”

BIOTRONIK, the German medical technology firm, is better known in the US for its cardiac rhythm management (CRM) devices and innovations, like the pioneering Home Monitoring^®, ProMRI^® and DX Systems. The company plans to add a complete Vascular Intervention division in the US to complement the already established CRM business, providing a full spectrum of care for patients with heart and vascular disease.

“Our mission is to improve and save patients’ lives with innovative devices such as the Orsiro hybrid DES,” said Dr. Daniel Bühler, President BIOTRONIK Vascular Intervention. “It is one of our most successful products globally and deservedly holds a place in the BIOTRONIK Masterpieces portfolio. With physicians relying on top performing tools for each and every procedure, we are very happy to move one step closer to delivering Orsiro to patients in the US.”

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

1. ^{TLF is defined as all cardiac death, target vessel Q-wave or non–Q-wave myocardial infarction (MI), or
   clinically-driven target lesion revascularization (TLR).}
2. ^{Pilgrim T, et al. Lancet. 2014, 384 (9960).}
3. ^{Windecker S. Results of the BIOFLOW II Trial Randomized Comparison of Orsiro with bioabsorbable polymer versus Xience Prime. Presented at: Transcatheter Cardiovascular Therapeutics (TCT); 27 Oct – 1 Nov 2013; San Francisco, California. ClinicalTrials.gov: NCT01356888.}
4. ^{Waltenberger J. BIOFLOW-III, more than 1300 Patient All Comers Registry with the Orsiro Hybrid Drug Eluting Stent – 12 months Clinical Data. Presented at: EuroPCR; May 21-24 2013; Paris, France. ClinicalTrials.gov: NCT01553526.}
5. ^{Jensen LO. Randomized comparison of a sirolimus-eluting stent with a biolimus-eluting stent in patients
   treated with PCI: the SORT OUT VII trial. Presented at: EuroPCR; May 19, 2015; Paris, France.
   ClinicalTrials.gov: NCT01879358.}
6. ^{CAUTION – Investigational device. Limited by United States law to investigational use.}