Orsiro Coronary Drug-Eluting Stent Receives Market Approval in Japan
BIOTRONIK announced today market approval for its Orsiro1 coronary drug-eluting stent (Orsiro DES) by the Japanese Ministry of Health. This 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 multi-center, international randomized controlled trial with a five-year follow-up.
“We are excited to make this innovative product available to Japanese patients together with Japan Lifeline, our distribution partner for Orsiro,” said Jeffrey Annis, Managing Director of BIOTRONIK Japan.
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, with more than 32,500 patients around the world enrolled in the Orsiro clinical program to date. Most recently, the BIOFLOW-V trial, published in The Lancet2, has shown significantly lower target lesion failure rates for Orsiro when compared to the Xience3 stent family.
“Japan is one of the most important markets in the world, and gaining access to it is a significant milestone for our DES program, as well as for making this innovative product available globally,” commented Dr. Alexander Uhl, Vice President of Marketing at BIOTRONIK Vascular Intervention.
Marketing Communication Manager
BIOTRONIK Japan. Inc.
Ebisu Business Tower 13F, 1-19-19 Ebisu Shibuya-ku
Tokyo, Japan 150-0013
Tel +81 (0) 3 3473 7476
1 CAUTION – Investigational device in the United States. Limited by US law to investigational use.
2 Kandzari D et al., Ultrathin Bioresorbable Polymer Sirolimus-Eluting Stents versus Thin Durable Polymer Everolimus-Eluting Stents in Patients Undergoing Coronary Revascularisation (BIOFLOW-V): a randomized trial, 2017, The Lancet. 2017
3 Xience is a registered trademark of Abbott Cardiovascular Systems Inc.
4 Not currently available in the United States.
BIOTRONIK is a leading medical device company that has been developing trusted and innovative cardiovascular and endovascular solutions for more than 50 years. Driven by a purpose to perfectly match technology with the human body, BIOTRONIK innovations deliver care that saves and improves the lives of millions diagnosed with heart and blood vessel diseases every year. BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries.