BIOTRONIK Announces First Patient Enrolled in BIOFLOW-VI Clinical Study in China

BUELACH, Switzerland, August 31, 2015 - BIOTRONIK, a leading manufacturer of cardio- and endovascular medical technology, announced today that the first patient has been enrolled in the BIOFLOW-VI clinical study in China. The results will be used to further demonstrate the safety and efficacy of BIOTRONIK’s Orsiro hybrid drug-eluting stent (DES) and support Chinese market approval. The first implantation was successfully performed by BIOFLOW-VI coordinating clinical investigator Dr. Yuejin Yang at the Fuwai Hospital, Beijing, China.

BIOFLOW-VI is a prospective, multi-center, randomized, controlled clinical trial. The study plans to enroll up to 440 patients at 15 study sites in China. Eligible patients with coronary artery disease will be randomized 1:1 to receive either Orsiro DES or Abbott Xience Prime everolimus-eluting stent (EES). The trial’s primary endpoint is in-stent late lumen loss (LLL) at nine months post–index procedure, and the main safety endpoint is major adverse cardiac event (MACE, e.g., death, myocardial infarction and stent thrombosis) at one year.

“Based on the wealth of clinical evidence demonstrating Orsiro’s safety and efficacy, I am very excited to begin enrollment in the BIOFLOW-VI study. This trial represents a key step in the process of bringing this remarkable product to Chinese patients,” commented Dr. Yang. “Once approved for use here, I’m convinced Orsiro will benefit Chinese patients and physicians as it does in Europe.”

Already widely used in Europe, Orsiro has consistently demonstrated efficacy and safety in numerous clinical trials, including more than 25,000 patients to date. The BIOSCIENCE trial, published in The Lancet¹, showed 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-II², a prospective, international, multi-center, randomized trial, which evaluated the safety and efficacy of Orsiro. Subgroup analyses of BIOFLOW-II and BIOFLOW-III³, 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 population⁴. In that trial, Orsiro demonstrated enhanced safety and a three-times reduced risk of stent thrombosis.

“Our mission is to improve and save patients’ lives all over the world with innovative devices like the Orsiro hybrid DES, which has proven itself time and again both in clinical studies and in routine clinical practice,” stated Gunnar Wochnowski, Vice President BIOTRONIK Asia Pacific. “The start of BIOFLOW-VI is an important milestone in our quest to bring Orsiro, one of our most successful products globally and a cornerstone of the BIOTRONIK Masterpieces portfolio, to China.”

1. ^{Pilgrim T. et al. Lancet. 2014, 384 (9960)}
2. ^{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}
3. ^{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}