OrbusNeich Medical said today that it enrolled the 1st U.S. patient in a pivotal trial of its dual-therapy Combo stent.
The 572-person, randomized, multi-center Harmonee study began in February 2014 in Japan. It’s designed to support Shonin approval there and meet feasibility trial requirements in the U.S., OrbusNeich said.
The ‘dual-therapy’ stent is designed to repair vessel injury and regenerate the endothelium, Hong Kong-based OrbusNeich said. The Combo stent won CE Mark approval in the European Union in 2013.
"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. This randomized, controlled trial is the 1st 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," principal investigator Dr. Roxana Mehran of New York’s Mount Sinai Medical Center said in a press release.
The trial is running under the joint U.S.-Japan "Harmonization-By-Doing" initiative, OrbusNeich said.
"We are delighted to confirm that the enrollment process for the Harmonee study in the U.S. has begun. With a unique 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," vice president Steve Rowland said in prepared remarks.