OrbusNeich Medical said it launched a clinical trial in the U.S. and Japan for its Combo dual-therapy coronary stent as it gears up to apply for Shonin approval in Japan.
The 572-patient trial will compare the Combo stent with Abbott‘s (NYSE:ABT) Xience V, Xience Prime and Xience Xpedition everolimus-eluting stents. The sirolimus-eluting Combo stent is also designed to capture endothelial progenitor cells using an antibody coating, according to a press release.
"The technology consists of an antibody surface coating that captures EPCs circulating in the blood to the device to form an endothelial layer that provides protection against thrombosis and modulates restenosis," OrbusNeich said. The Combo stent won CE Mark approval in the European Union last year.
The trial is being run under a single U.S.-Japan protocol, as a "Global Clinical Trial ‘proof-of-concept’ under the framework of the joint Japan-U.S. Harmonization-By-Doing initiative," according to the release. The results will also be used to win pilot trial status from the FDA, OrbusNeich said.
“This registration trial is an important milestone for interventional cardiologists and patients in Japan,” co-principal investigator Dr. Shigeru Saito of the Shonan Kamakura General Hospital said in prepared remarks. “The study will investigate the clinical performance of the groundbreaking Combo Stent, which combines drug eluting technology for control of neointimal proliferation along with EPC capture technology for promoting early endothelialization. Furthermore, this trial design innovates on the traditional framework for clinical trials using a unique Japan-U.S. collaboration, such that one can say that the first step to “creating the future” has just been taken.”
"While the field of drug eluting stents is mature, the Harmonee study breaks new ground with many important ‘firsts,’" add co-principal investigator Dr. Mitchell Krucoff of Duke University Medical Center. "This is the 1st 4-component drug-eluting stent to seek registration, combining healthier stent-site healing through biological capture of circulating endothelial progenitor cells to other ‘best in class’ safety features such as sirolimus elution through abluminal coated, bioabsorbable polymer. And this is the first pivotal stent study where co-enrollment in both Japan and the U.S. will help bring forward this new device in both nations through regulatory harmonization. Finally, this is the first stent study using both physiologic and anatomic assessment of the long-term result, as well as high resolution imaging of endothelial recovery."
The Hong Kong-based company closed a long-running patent war with Boston Scientific (NYSE:BSX) last September when Boston agreed to pay an undisclosed amount to settle infringement proceedings in the U.S., the U.K., Germany and Holland.
Chris Walker contributed to this report.