OrbusNeich's Combo Dual-Therapy Stent Receives CE Mark Approval

May 27, 2013—OrbusNeich (Fort Lauderdale, FL) announced CE Mark approval and the launch of the Combo dual-therapy stent for the treatment of coronary artery disease. The Combo stent is being introduced in Europe and selected markets in the Asia Pacific and Middle East regions.

According to the company, the Combo stent was developed to address the challenges of delayed healing of the coronary artery associated with monotherapy drug-eluting stents. The Combo dual-therapy stent both accelerates endothelial coverage and controls neointimal proliferation through the combination of OrbusNeich's prohealing technology with an abluminal sirolimus drug elution delivered from a biodegradable polymer that achieves full and complete dissipation by 90 days.

In the company's press release, Roxana Mehran, MD, of Mount Sinai Medical Center in New York, New York, commented, “I believe that Combo is the next next-generation drug-eluting stent, combining the antirestenotic property of drug-eluting stents with endothelial progenitor cell (EPC) capture, which is able to heal the surface of the stent. We're 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.”

OrbusNeich advised that CE Mark approval was supported by clinical outcomes from the REMEDEE study, which confirmed that the Combo stent is as effective as a monotherapy drug-eluting stent with respect to in-stent late lumen loss at 9-month angiographic follow-up. Prof. Michael Haude, MD, served as Principal Investigator of the REMEDEE trial. Prof. Haude is Director of Medical Clinic I at the Lukaskrankenhaus in Neuss, Germany.

In the press release, Prof. Haude stated, “Late stent thrombosis is still a concern for patients treated with monotherapy drug-eluting stents, leaving them dependent on a minimum of 6 months DAPT. 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.”

In the announcement, Renu Virmani, MD, of the CVPath Institute Inc. in Gaithersburg, Maryland, explained the implications of the Combo stent's EPC capture technology. Dr. Virmani stated, “Studies have shown that drug-eluting stents adversely impact endothelial proliferation, migration, and function. Conversely, EPCs have the ability to migrate to areas of vascular injury and aid in the regeneration of damaged and dysfunctional endothelium. By combining drug elution with the EPC capture technology, the Combo stent may restore endothelial function. In addition, the Combo stent is the only stent with full and complete polymer degradation within 90 days, affording it the safety profile of a bare-metal stent with the added benefit of allowing healing while suppressing smooth muscle cell proliferation.”