OrbusNeich has announced that the first U.S. patient has been enrolled in the HARMONEE (Harmonized Assessment by Randomized, Multi-center Study of OrbusNEich's COMBO StEnt) stent study. The study is being conducted under the framework of the joint Japan-U.S. Harmonization-By-Doing (HBD) initiative and will support the company's planned application for Shonin approval in Japan and to meet the feasibility trial requirements in the U.S.
