Coronary Drug-Eluting Stent Receives Market Approval in Japan

Biotronik has announced market approval for its Orsiro 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-centre, international randomised 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.

“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.