OrbusNeich has announced that two major clinical studies have now completed enrolment. The studies—HARMONEE (Harmonized assessment by randomised, multicentre study of OrbusNeich’s Combo stent) and RECOVERY—involve more than 1,000 patients at over 50 study locations throughout Japan, the USA and China. Both studies are randomised trials comparing the Combo dual therapy stent (DTS) to market leaders.
HARMONEE is being conducted to demonstrate the effectiveness of the device compared with the Abbott Vascular Xience stent in the treatment of significant ischaemic heart disease. It is being carried out under the framework of the joint Japan-US “Harmonisation-By-Doing (HBD)” initiative and will support the company’s planned application for approval in Japan and to meet the feasibility trial requirements in the US. The RECOVERY study is designed to evaluate the Combo dual therapy stent compared to the Nano stent from Lepu Medical Technology and will be used to support the submission for market approval in China. One-year results from both trials are expected in the second half of 2017.
Wayne Johnson, president and chief executive officer, OrbusNeich, says: “We are pleased to have completed enrolment on four significant trials so far this year. The HARMONEE and RECOVERY studies follow the MASCOT registry and REDUCE trial, both of which completed enrolment last spring. With over 7,000 patients documented in our Combo clinical programme, we are well placed to build further compelling evidence for Combo as well as gaining market approval in the major markets of China and Japan.”