The first patient has been enrolled in the BIOFLOW-VI clinical study in China. The aim of the study is further demonstrate the safety and efficacy of a hybrid drug-eluting stent (Orsiro, Biotronik) and support Chinese market approval. A press release reports that the first implantation was successfully performed by BIOFLOW-VI coordinating clinical investigator Yuejin Yang at the Fuwai Hospital, Beijing, China.
According to the press release, Orsiro is a hybrid solution that combines passive and active components—a proBIO passive coating encapsulates the stent and is designed to minimise interaction between the metal stent and the surrounding tissue and BIOlute active coating contains a biocompatible polymer that delivers a limus drug via a biodegradable matrix. The press release notes that this hybrid coating is layered on top of the PRO-Kinetic Energy stent platform.
The BIOFLOW-VI is a prospective, multicentre, randomised, controlled clinical trial. The aim is to enrol up to 440 patients at 15 study sites in China. Eligible patients with coronary artery disease will be randomised 1:1 to receive either the Orsiro drug-eluting stent or an everolimus-eluting stent with a permanent polymer (Xience Prime, Abbott Vascular). The trial’s primary endpoint is in-stent late lumen loss at nine months post–index procedure, and the main safety endpoint is major adverse cardiac event (MACE) at one year.
Yang comments: “Based on the wealth of clinical evidence demonstrating Orsiro’s safety and efficacy, I am very excited to begin enrolment 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 am convinced Orsiro will benefit Chinese patients and physicians as it does in Europe.”