OrbusNeich said today it launched a Chinese trial of its Combo dual-therapy coronary stent designed to repair vessel injury and regenerate endothelium.
The 436-patient randomized, non-inferiority trial has enrolled its 1st patient, the Hong Kong-based company said, and will compare the Combo stent’s effectiveness against Lepu Medical‘s Nano stent for up to 5 years.
“We are pleased to announce the enrollment and treatment procedure of the 1st patient with the Combo stent and anticipate further enrollment to continue over the coming months. This trial will deliver significant data that will provide physicians with valuable knowledge to make the best treatment decisions for their patients in China and beyond,” R&D veep Steve Rowland said in prepared remarks.
In May, OrbusNeich said it enrolled the 1st U.S. patient in a pivotal combined U.S. and Japanese trial of its Combo stent. The 572-person, randomized, multi-center Harmonee study began in February 2014 in Japan. The trial is designed to support Shonin approval there and meet feasibility trial requirements in the U.S., OrbusNeich said.