Regulatory News

First Dual-Therapy Stent Nets CE Mark

OrbusNeich’s Combo Dual Therapy Stent has received a CE mark and has been introduced in Europe and select markets in Asia Pacific and the Middle East.

The stent, which is the first dual-therapy stent, is designed to address the challenges of delayed healing of the coronary artery associated with monotherapy drug-eluting stents. According to a press release, the Combo Dual Therapy Stent is the first stent to both accelerate endothelial coverage and control neointimal proliferation through the combination of a proven pro-healing technology with an abluminal sirolimus drug elution delivered from a biodegradable polymer that achieves complete dissipation by 90 days. The technology is composed of an antibody surface coating that captures endothelial progenitor cells (EPCs) to the device to form an endothelial layer that provides protection against thrombosis and modulates restenosis.

Roxana Mehran

Roxana Mehran

“I believe that Combo is the next next-generation DES, combining the anti-restenotic property of DES with EPC capture, which is able to heal the surface of the stent,” Roxana Mehran, MD, with Mount Sinai Medical Center, New York, and Associate Medical Editor of Cardiology Today’s Intervention, said in the release. “We’re most excited about the possibility of actually having a stent for which you do not need prolonged dual antiplatelet therapy, 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.”

OrbusNeich’s Combo Dual Therapy Stent has received a CE mark and has been introduced in Europe and select markets in Asia Pacific and the Middle East.

The stent, which is the first dual-therapy stent, is designed to address the challenges of delayed healing of the coronary artery associated with monotherapy drug-eluting stents. According to a press release, the Combo Dual Therapy Stent is the first stent to both accelerate endothelial coverage and control neointimal proliferation through the combination of a proven pro-healing technology with an abluminal sirolimus drug elution delivered from a biodegradable polymer that achieves complete dissipation by 90 days. The technology is composed of an antibody surface coating that captures endothelial progenitor cells (EPCs) to the device to form an endothelial layer that provides protection against thrombosis and modulates restenosis.

Roxana Mehran

Roxana Mehran

“I believe that Combo is the next next-generation DES, combining the anti-restenotic property of DES with EPC capture, which is able to heal the surface of the stent,” Roxana Mehran, MD, with Mount Sinai Medical Center, New York, and Associate Medical Editor of Cardiology Today’s Intervention, said in the release. “We’re most excited about the possibility of actually having a stent for which you do not need prolonged dual antiplatelet therapy, 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.”