CE mark for Combo dual therapy stent


OrbusNeich has announced that it has received the CE mark for its dual therapy coronary stent (Combo), and that it has launched the device in Europe and markets in Asia Pacific and Middle East Regions.

According to a company press release, the Combo dual therapy stent is the first stent to both accelerate endothelial coverage and control neo-intimal proliferation through the combination of OrbusNeich’s pro-healing technology with an abluminal sirolimus drug elution delivered from a biodegradable polymer that achieves full and complete dissipation by 90 days.

Roxana Mehran, Mount Sinai Medical Center, USA, said, “I believe that Combo is the next-next-generation drug-eluting stent, combining the anti-restenotic property of drug-eluting stents with endothelial progenitor cell capture, which is able to heal the surface of the stent. We are most excited about the possibility of actually having a stent for which you do not need prolonged dual antiplatelet therapy (DAPT), and I think that is the future. Obligatory, prolonged DAPT is no longer going to be the standard – we cannot accept that anymore. And so, we’re looking for a safer stent, and I think this very unique and interesting platform has incredible promise.”

Nine-month clinical outcomes from the REMEDEE study confirmed that the COMBO Stent is as effective as a monotherapy drug-eluting stents, with respect to in-stent late lumen loss at nine-month angiographic follow-up. These data were used to support CE Mark approval for COMBO.

“Late stent thrombosis is still a concern for patients treated with monotherapy drug-eluting stent, leaving them dependent on a minimum of six months DAPT,” said Michael Haude, director of Medical Clinic I at the Lukaskrankenhaus in Neuss, Germany, and principal investigator of the REMEDEE trial. “We also know that cessation of DAPT is the single most significant predictor of stent thrombosis for these patients. If cessation of DAPT is necessary, the Combo stent may enable us to stop DAPT without causing a catastrophic event. Thus the Combo stent has the potential to bring the best of both worlds together, balancing safety and efficacy.”

The addition of OrbusNeich’s proprietary pro-healing antibody surface coating provides protection against stent thrombosis by capturing
endothelial progenitor cells circulating in the blood to the device to form a functional endothelial layer.