OrbusNeich touted results today from a pivotal registration study comparing its Combo dual therapy stent with Abbott‘s (NYSE:ABT) Xience stent in patients with ischemic heart disease.
The trial is designed to evaluate the effectiveness of OrbusNeich’s combined endothelial progenitor cell capture and drug-eluting stent. The data showed that the device is non-inferior to Abbott’s drug-eluting stent after 12 months, with a 7% rate of target vessel failure in the Combo group and 4.2% in the Xience group.
“Achieving non-inferiority in TVF compared to the best-in-class current DES, with the addition of superior surrogate measures of site healing by Combo in this randomized study, represents the opening of an exciting new chapter in percutaneous coronary intervention device design targeting enhanced safety and effectiveness for patients with coronary artery disease,” principal investigator Mitchell Krucoff said in prepared remarks.
An independent lab reported in-stent late loss after one year of 0.293 mm in the Combo group compared with 0.219 mm in the Xience group, as well as in-segment late loss of 0.229 mm compared with 0.22 mm, respectively.
Angiographic in-stent restenosis of Combo compared to Xience was 1.3% compared to 2.6%, the company reported, and in-segment restenosis was 2.5% compared to 3.9%.
OrbusNeich also said that optical coherence tomography after one year showed significantly better healthy tissue strut coverage in the Combo group than in the Xience group.
The company plans to use results from the Harmonee trial to support its application for approval in Japan and to satisfy trial requirements in the U.S.
