Biotronik said today it enrolled the 1st patient in its new Chinese Bioflow-VI study of its Orsiro drug-eluting stent for treating patients with coronary artery disease.
The prospective, multi-center trial is slated to enroll 440 patients at 15 sites in China to support Chinese market approval of the Orsiro drug-eluting stent.
“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,” coordinating clinical investigator Dr. Yuejin Yang said in a press release.
The primary endpoint for the study is in-stent late lumen loss at 9 months and the primary safety endpoint is the rate of major adverse cardiac events at 1 year, according to the company.
“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. 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,” Biotronic Asia Pacific veep Gunnar Wochnowski said in prepared remarks.
Earlier this month, Biotronik announced 2 new studies that are slated to examine the company’s CRT-D device and BioMonitor implanted cardiac monitor.
A 277-patient BioContinue clinical trial will examine the risk of ventricular arrhythmias after CRT-D replacement, enrolling patients over 2 years at 40 centers across 8 countries, the company said.
Another trial, the BioGuard MI1 study, will examine the effectiveness of Biotronik’s BioMonitor at reducing the likelihood of major adverse cardiovascular events in patients with relatively preserved ejection fraction who have experienced myocardial infarction.