OrbusNeich, a global company that designs, develops, manufactures and markets innovative medical devices for the treatment of vascular diseases, announced long-term results from its REMEDEE trial. In addition to showing that the COMBO Dual Therapy Stent shows no late target lesion revascularization, the results demonstrate that the stent proactively promotes functional vessel healing.
Key findings include: Target lesion revascularization remained stable at 5.7 percent in both years two and three of the follow up on the REMEDEE trial; No thrombotic events over three years; 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."
"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.
"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."
"Based on our extensive clinical programme, 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."
The COMBO Dual Therapy Stent is the first dual therapy stent to both accelerate endothelial coverage and control neo-intimal proliferation through the combination of the proven pro-healing technology with an abluminalsirolimus drug elution delivered from a biodegradable polymer that achieves full and complete dissipation by 90 days.
OrbusNeich's patented 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.