Long-term Data Supports OrbusNeich Combo™, “First and Only” Dual Therapy Stent

Last time we wrote about OrbusNeich’s dual therapy stent the company was starting to enrol patients in its post-marketing registry. Now the company is updating us with long-term results from its REMEDEE Trial in which the COMBO™ Dual Therapy Stent shows no late target lesion revascularization and seems to proactively promote functional vessel healing.

Background

OrbusNeich’s COMBO Dual Therapy Stent is the first dual therapy stent intended to to both accelerate endothelial coverage and control neo-intimal proliferation through the combination of the proven pro-healing technology with an abluminal sirolimus drug elution delivered from a biodegradable polymer that achieves full and complete dissipation by 90 days.

OrbusNeich’s patented 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.

Key findings from the REMEDEE trial include stable Target Lesion Revascularization rate of 5.7 percent in both years two and three follow up. There were no thrombotic events reported over three years with complete polymer degradation and drug release by 90 days.

Results were released during EuroPCR 2014 in Paris, at a symposium titled, “Achieving the Goal of Stenting: the COMBO Dual Therapy Stent for an Open, Stable and Healed Coronary Artery.”

Physician comments

“Many stents claim healing, but the COMBO stent has proven to have good healing properties in both clinical and pre-clinical settings. The dual therapy approach of the COMBO stent makes it the only stent that can claim rapid endothelialization,” said Dr. Virmani, co-chair of the symposium and president of CVPath Institute, Gaithersburg, Maryland, USA.

Investigator comments

“Many of the problems associated with traditional drug-eluting stents stem from the delayed endothelialization that is common with mono therapy,” said Michael Haude, M.D. Lukaskrankenhaus, Neuss, Germany who presented the REMEDEE long-term data. “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 three years, and no thrombotic events over the same period.”

Company comments

“Based on our extensive clinical program, we believe the COMBO stent can deliver short-term benefits in the form of rapid endothelial coverage and the potential for shorter dual antiplatelet therapy; the mid-term benefit of control of neo-intimal proliferation; and the longer-term outcome of stable, consistent, long-lasting healing,” said B. Wayne Johnson, president and chief operating officer of OrbusNeich. “The clinical data presented at EuroPCR validate what we have seen in clinical practice and illustrate that the COMBO stent delivers more than healing. It restores true vessel function.”

Source: OrbusNeich, PR Newswire

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