Enrollment Completed in REMEDEE Postmarket Registry of OrbusNeich's Combo Dual-Therapy Stent

March 28, 2014—OrbusNeich (Fort Lauderdale, FL) announced the completion of enrollment in the REMEDEE postmarket registry evaluating the company’s bioengineered, abluminal sirolimus-eluting Combo stent for the treatment of coronary lesions in the setting of routine clinical care. The prospective, multicenter, all-comers registry enrolled 1,000 patients at nine European high-volume percutaneous coronary intervention centers in France, Latvia, Luxembourg, The Netherlands, the United Kingdom, and Spain. Robbert de Winter, MD, of the Academic Medical Center in Amsterdam, The Netherlands, serves principal investigator of the study.

In the company’s press release, Dr. de Winter commented, “The REMEDEE Registry will evaluate the long-term safety and performance for the Combo stent in a real-world patient population. This innovative device allows for accelerated stent endothelialization and healing and therefore addresses the challenge of delayed arterial healing caused by monotherapy drug-eluting stents. We expect primary endpoint data in the second quarter of 2015.”

OrbusNeich advised that the registry’s primary endpoint is clinically driven target vessel failure (TVF) at 1 year postprocedure. TVF includes cardiac death, target vessel myocardial infarction (MI), and ischemia-driven target vessel revascularization.

The study’s secondary endpoints include device and procedural success and adjudicated target lesion failure at 30 and 180 days postprocedure. Additional secondary endpoints to be evaluated at 30, 180, and 365 days include the components of TVF; adjudicated major adverse cardiac events as a composite and as each of its components, defined as death, any MI, and any revascularization; and adjudicated stent thrombosis. Clinical follow-up will be conducted annually up to 5 years.

OrbusNeich stated that the Combo dual-therapy stent is designed to accelerate endothelial coverage and control neointimal proliferation through the combination of its pro-healing technology with abluminal sirolimus drug elution delivered from a biodegradable polymer that achieves full and complete dissipation by 90 days. OrbusNeich’s 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.

In May 2013, OrbusNeich announced that the Combo dual-therapy stent received European CE Mark approval. In August 2013, the company announced the beginning of enrollment in the REMEDEE registry. The Combo stent is an investigational device and not available for sale in Japan and the United States.