"Healing" sirolimus-eluting coronary stent gets market approval in Europe

May 29, 2013

Hong Kong, China - A sirolimus-eluting stent with an antibody-coated surface that attracts endothelial progenitor cells (EPCs) has received the CE Mark, paving the way to commercialization in Europe, according to the device's manufacturer, OrbusNeich [1]. The company said it is also simultaneously launching the device, the COMBO Dual Therapy Stent, in Asia and the Middle East.

CE Mark was granted largely on the strength of the randomized REMEDEE safety and efficacy study, which compared the COMBO stent with the paclitaxel-eluting Taxus Libert é stent (Boston Scientific) in patients with non-acute symptomatic coronary artery disease. The stents were similarly effective for the primary outcome of in-stent late lumen loss at nine months. Follow-up to five years is planned for in-stent restenosis and all-cause mortality and other clinical outcomes.

The COMBO stent's novel feature, a "cell-capture coating" containing anti-CD34 antibodies with affinity for circulating EPCs, is intended to accelerate the endothelialization process that helps protect against in-stent thrombosis. To some degree, the cell-capture coating's role is as an antidote to the sirolimus, which is thought to delay endothelialization.

OrbusNeich explored the effectiveness of the antibody-coating technology in several trials using its Genous stent, which lacked the antiproliferative component, both on its own (delivered on a conventional balloon) and deployed on a paclitaxel-coated balloon. Results in those studies were mixed but generally didn't favor the Genous.

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