Biotronik touted data today from the BioFlow-IV study of its Orsiro hybrid drug-eluting stent at this year’s Japan Circulation Society congress.
The company’s study enrolled 579 patients with de novo coronary lesions and randomized them to receive either the Orsiro stent or Xience stent. After 12 months, the researchers confirmed non-inferiority of its stent, based on the primary endpoint of target vessel failure.
“In the Bioflow-IV study, the excellent efficacy and safety profiles of Orsiro was confirmed. This outcome is consistent with the outcomes of other Orsiro clinical studies conducted outside Japan,” clinical investigator Dr. Shigeru Saito said in prepared remarks. “I look forward to seeing Orsiro obtain premarket approval from the Japanese government and being made available to Japanese patients.”
The Orsiro stent launched in 2011 and is widely used in Europe, according to Biotronik. The drug-eluting device features a hybrid of passive and active components, including a coating with biocompatible polymer that delivers a drug using a bioabsorbable matrix.
Biotronik’s Orsiro stent is an investigational device in Japan and the company said it hopes that this clinical data will help to support its submission for regulatory approval.
“Ultra-thin 60 μm Orsiro DES had no stent fracture in an accelerated 10-year durability testing performed at our institute,” Dr. Kiyotaka Iwasaki, of Waseda University, said. “This device has potential to provide more benefits to long-term patients’ safety.”
“This clinical data represents a significant milestone in helping to bring this product to the Japanese market. We look forward to making this product available to Japanese customers together with our distribution partner for Orsiro, Japan Lifeline,” managing director of Biotronik Japan, Jeffrey Annis, added.