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FDA approves Rebel bare-metal stent system
Boston Scientific announced that the FDA has approved its Rebel platinum chromium coronary stent system, a bare-metal stent system intended to treat CAD.
According to a press release, the stent features a platinum chromium alloy and a customized architecture design. It provides an identical platform to the Promus Premier drug-eluting stent, but does not include the administration of everolimus. The Rebel stent features a shorter, more visible tip, a dual-layer balloon and an inner lumen catheter intended to improve delivery precision for complex lesions, according to the release. It is available in a matrix of 46 sizes, with diameters ranging from 2.25 mm to 4.5 mm and lengths from 8 mm to 32 mm.
The approval follows results from the OMEGA clinical trial; a single-arm, multicenter trial conducted throughout the United States that indicated low rates of adverse events at 9 months after implantation of the Rebel system. The company obtained a CE mark for the Rebel system in February.
“Bare-metal stents are an important part of our practice, as not every patient can receive a drug-eluting stent,” John C. Wang, MD, of Medstar Union Memorial Hospital in Baltimore, said in the release. “This new bare-metal stent has the same … visibility and deliverability as the Premier DES but allows me to treat patients who are not candidates for DES therapy.”