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OrbusNeich Begins Dual Therapy Stent Study

Trial will enroll patients in up to 50 locations in Japan, U.S.

By: Michael Barbella

Managing Editor

OrbusNeich has enrolled the first U.S. percutaneous coronary intervention patients in its new stent study.

The HARMONEE (Harmonized Assessment by Randomized, Multi-center Study of OrbusNEich’s COMBO StEnt) clinical trial will evaluate the company’s Combo dual therapy stent, designed to repair vessel injury and regenerate endothelium, which lines the vessels. It is the only stent in the world capable of doing this, the company claims.

The clinical trial is being carried out under the auspices of the Japan-U.S. Harmonization-By-Doing initiative, and is intended to support the devicemaker’s application for Japanese Shonin approval and meet U.S. feasibility trial requirements.

“We are delighted to confirm that the enrollment process for the HARMONEE study in the U.S. has begun,” said Steve Rowland, vice president of Research and Development at OrbusNeich. “With a Japan-U.S. collaboration involving co-enrollment in both countries and a single Japan-U.S. protocol, this regulatory harmonization will help bring forward new options for patients with coronary artery disease in both countries.”

The study is a multi-center, single-blind, randomized, active-controlled clinical trial in percutaneous coronory intervention subjects. Several additional sites are open and actively screening.

A total of 572 patients will be enrolled at up 50 locations in Japan and the United States. The first patient was enrolled at Shonan Kamakura General Hospital in Kanagawa Prefecture, Japan, in February 2014. The study’s 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 or angiography to determine ischemia-driven TVR.

“The enrollment of the first U.S. patient marks a key milestone in the initiation of the U.S. Investigational Device Exemption portion of the HARMONEE study,” said Roxana Mehran, M.D., director of Interventional Cardiovascular Research and Clinical Trials at Mount Sinai Medical Center in New York, N.Y., and U.S. principal investigator. “This randomized controlled trial is the first to use both physiologic and anatomic assessment of the long-term result of the stent procedure, as well as using high-resolution imaging of vascular healing, and it will provide important data that will inform the care of patients with coronary artery disease.”

COMBO is a dual therapy stent designed to repair vessel injury and regenerate endothelium, fostering natural, true vessel healing, according to OrbusNeich. It does this by accelerating endothelial coverage and controlling neo-intimal proliferation. This is done through a combination of the EPC capturing techology and a sirolimus drug elution, delivered from a bioresorbable polymer that is completely degraded within 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 the device to form an endothelial layer that provides protection against thrombosis and modulates restenosis.

Based in Hong Kong China, OrbusNeich designs, develops, manufactures and markets vascular disease treatment devices.

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