August 30, 2015
BIOFLOW-VI Clinical Study of Biotronik's Orsiro DES Begins in China
August 31, 2015—Biotronik announced 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 the company's Orsiro hybrid drug-eluting stent (DES) and support Chinese market approval. The first implantation was successfully performed by BIOFLOW-VI Coordinating Clinical Investigator Yuejin Yang, MD, at the Fuwai Hospital in Beijing, China.
According to Biotronik, BIOFLOW-VI is a prospective, multicenter, randomized controlled clinical trial that 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 undergo treatment with either the Orsiro DES or the Xience Prime everolimus-eluting stent (Abbott Vascular). The trial’s primary endpoint is in-stent late lumen loss at 9 months after the index procedure, and the main safety endpoint is the 1-year rate of major adverse cardiac events, defined as death, myocardial infarction, and stent thrombosis.
In Biotronik’s announcement, Dr. Yang commented, “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. Once approved for use here, I’m convinced Orsiro will benefit Chinese patients and physicians as it does in Europe.”
The Orsiro device was launched in Europe in 2011 and has consistently demonstrated safety and efficacy in numerous clinical trials, including more than 25,000 patients to date, stated the company.