OrbusNeich Initiates Harmonee Study in Japan to Evaluate Stent

OrbusNeich has enrolled its first patient in a two-country proof-of-concept study for its Combo Dual Therapy Stent.

The Hong Kong, China-based medical device maker announced the start of clinical trials for a stent clinicians claim is the first of its kind. The first patient is Shonan Kamakura General Hospital in Japan. The trial is aiming for 572 patients at more than 50 sites across the U.S. and Japan. Patients presenting with ischemic coronary disease and non-ST segment myocardial infarction (NSTEMI) will be randomized one-to-one to treatment with a Combo stent or an everolimus-eluting stent comparator. The study’s primary endpoint is a comparison of clinically driven target vessel failure, defined as cardiac death, target vessel myocardial infarction or ischemia-driven target vessel revascularization (TVR) by percutaneous or surgical methods. All patients will undergo fractional flow reserve (FFR) or angiography to determine ischemia-driven TVR.

“This registration trial is an important milestone for interventional cardiologists and patients in Japan,” said Shigeru Saito, M.D., vice director of Shonan Kamakura General and co-principal investigator of the study. “The study will investigate the clinical performance of the 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.”

The Harmonee study design consists of three cohorts, each with equal number of patients receiving either the Combo stent or a control stent. The first cohort includes 30 patients who will undergo assessment by FFR and quantitative coronary angiography (QCA) at 12 months and optical coherence tomography (OCT) at six and 12 months. The second cohort consists of 110 patients who will undergo assessment by FFR, QCA and OCT at 12 months. The third cohort of 432 patients will undergo assessment by FFR and QCA at 12 months.

Mitchell Krucoff, M.D., of Duke University Medical Center, Durham, N.C., and study co-principal investigator, said, “The Japan-U.S. Harmonee study is very exciting for the future of patient care and of clinical trials treating coronary disease. While the field of drug eluting stents is mature, the Harmonee study breaks new ground with many important “firsts.” This is the first four-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. This is certainly not ‘just another’ stent study.”

The Combo Dual Therapy Stent is a dual therapy stent that accelerates endothelial coverage and controls neo-intimal proliferation through the combination of pro-healing technology with an abluminal sirolimus drug elution delivered from a biodegradable polymer that achieves full and complete dissipation by 90 days.

OrbusNeich’s patented endothelial progenitor cell (EPC) capture technology promotes the accelerated natural healing of the vessel wall after the implantation of blood-contact devices such as stents. The technology consists of an antibody surface coating that captures EPCs circulating in the blood to form an endothelial layer that provides protection against thrombosis and modulates restenosis.

The Combo Dual Therapy Stent has received CE Mark approval in Europe but is still considered an investigational device and therefore is not available for sale in Japan or the United States.

OrbusNeich designs, develops, manufactures and markets vascular disease treatment devices. The firm has operations in Shenzhen, China; Fort Lauderdale, Fla.; Hoevelaken, The Netherlands; and Tokyo, Japan. OrbusNeich supplies medical devices to interventional cardiologists in more than 60 countries.