OrbusNeich Medical today said it won market approval in Japan for its Combo Plus coronary stent.
The Combo Plus stent is designed to address the risk of stent thrombosis associated with delayed healing in conventional drug-eluting stents. The Combo Plus DES uses endothelial progenitor cell capture technology and abluminal sirolimus drug elution delivered from a biodegradable matrix polymer that fully dissipates within 90 days, according to the Hong Kong-based company.
A clinical trial found that the stent was non-inferior in one-year target vessel failure compared to an everolimus-eluting stent. Combo Plus also had a better healthy stent strut coverage compared to the EES control.
“The OrbusNeich Combo DES with endoluminal biologic endothelial progenitor cell capture technology has just become the first coronary device approved for clinical use in Japan based on the Harmonee study which enrolled both Japanese and US human subjects in a single prospective randomized trial protocol,” co-principal investigator Dr. Mitchell Krucoff said in a news release. “Not only is this a huge success for the Combo DES, but it is also a first-in-kind proof of concept for the Japan-USA Harmonization By Doing program.”
The device has also been shown to promote functional endothelial layer formation for protection against thrombosis and modulates restenosis.
“The market approval of the Combo Plus coronary stent in Japan is a tremendous achievement for the entire OrbusNeich organization,” added president & CEO David Chien. “A well-coordinated global effort was required to obtain the Japan market approval of a unique product such as the Combo Plus coronary stent. We expect this approval to allow OrbusNeich to build on our strong market position in the Japan percutaneous interventional market.”