Three-Year Data Presented for OrbusNeich's Combo Dual-Therapy Stent

May 23, 2014—OrbusNeich announced that long-term results from the REMEDEE trial of the company’s Combo dual-therapy stent were presented at a symposium during the EuroPCR 2014 congress held May 20–23, in Paris, France. The data showed no late target lesion revascularization (TLR) and demonstrated that the stent proactively promotes functional vessel healing. 

Michael Haude, MD, of Lukaskrankenhaus in Neuss, Germany, presented the REMEDEE long-term data. Cardiovascular pathologist Renu Virmani, MD, who is President of CVPath Institute in Gaithersburg, Maryland, cochaired the OrbusNeich symposium at EuroPCR.

In the company’s press release, Dr. Haude commented, “Many of the problems associated with traditional drug-eluting stents stem from the delayed endothelialization that is common with monotherapy. This delayed healing is associated with the critical issues of late catch-up and neoatherosclerosis. In contrast, the clinical data we presented on the Combo dual-therapy stent during EuroPCR 2014 showed a stable TLR rate that remains low (5.7%) at 3 years and no thrombotic events over the same period.”

Dr. Virmani stated, “Many stents claim healing, but the Combo stent has proven to have good healing properties in both clinical and preclinical settings. The dual-therapy approach of the Combo stent makes it the only stent that can claim rapid endothelialization.”

As summarized by OrbusNeich, the key findings were that the TLR rate remained stable at 5.7% at 2- and 3-year follow-up, there were no thrombotic events within 3 years, and there was complete polymer degradation and drug release by 90 days.

The Combo dual-therapy stent both accelerates endothelial coverage and controls neointimal proliferation through the combination of the company’s prohealing technology and abluminal sirolimus drug elution delivered from a biodegradable polymer that achieves dissipation by 90 days. OrbusNeich’s endothelial progenitor cell capture technology is designed to promote 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 endothelial progenitor cells circulating in the blood to the device to form an endothelial layer that provides protection against thrombosis and modulates restenosis, advised the company.