The Combo Dual Therapy device is hailed by OrbusNeich (Hoevelaken, Netherlands) as the first example of a dual therapy stent. The product combines abluminal sirolimus drug elution for the control of neointimal proliferation with the company’s proprietary Genous Pro-healing technology to promote endothelial coverage. On the luminal side of the stent are immobilized antibodies that capture circulating endothelial progenitor cells.
“The Combo Dual Therapy Stent is OrbusNeich’s latest innovation to leverage Genous, our proprietary pro-healing stent technology, to address the significant clinical risk of delayed or absent healing that faces drug eluting stents today,” explained Al Novak, OrbusNeich’s chairman of the board, president, and CEO in a statement.
The company recently announced the results of its REMEDEE trial (which is short for Randomized Evaluation of an abluMinal sirolimus coatED bio- Engineered stEnt) and found that it was comparable in performance to the TAXUS Liberté paclitaxel-eluting stent with respect to in-stent late lumen loss at a nine-month angiographic follow-up. As for the actual data, the in-stent late lumen loss for the Combo Dual Therapy Stent was 0.39 ±0.45 mm compared to 0.44 ±0.56 mm for the TAXUS drug-eluting stent.
While the stent proved to be comparable to the TAXUS device, the “real differentiating factor for Combo is the Genous pro-healing technology,” explained Michael Haude, MD, director of Medical Clinic I at the Lukaskrankenhaus (Neuss, Germany) in a press release. “Using intravascular ultrasound and optical coherence tomography imaging, we saw superb homogenous coverage of the Combo stent struts at nine months, compared to less impressive coverage with TAXUS.”
The stent is now pending CE Mark approval in Europe.
Flashbacks: OrbusNeich’s Genous Stent Technology Proven Safe in High Risk Patients; Sapphire II Coronary Dilation Catheter Gets Clearance in Europe; OrbusNeich’s Coronary Stent Shows Complete Neointimal Coverage in 26 Days