According to a Biotronik press release, the Japanese Ministry of Health has approved the company’s Orsiro coronary stent—a sirolimus-eluting stent with a biodegradable polymer—for the Japanese market.
The press release reports that the approval was supported by the positive 12-month outcomes of the BIOFLOW-IV clinical study, which were presented at the 81st Japan Circulation Society congress. The BIOFLOW-IV study is a prospective multicentre, international randomised controlled trial with a five-year follow-up.
The press release notes that with its ultrathin 60 micron struts (≦3.0mm in diameter) and unique proBIO coating which reduces nickel ion release, Orsiro has consistently displayed its effectiveness and safety in numerous clinical trials—more than 32,500 patients around the world have been enrolled in the Orsiro clinical programme to date. Most recently, the BIOFLOW-V trial, published in The Lancet, has shown significantly lower target lesion failure rates for Orsiro when compared with the Xience stent family.
“Japan is one of the most important markets in the world, and gaining access to it is a significant milestone for our drug-eluting stent programme, as well as for making this innovative product available globally,” comments Alexander Uhl, vice Ppresident of Marketing at BIOTRONIK Vascular Intervention.