Boston Scientific’s Bare Metal Rebel Stent Gets CE Mark

Boston Scientific’s Rebel Platinum Chromium Coronary Stent System has gained CE Mark approval for patients with coronary artery disease, the devicemaker said Wednesday.

The stent system is meant to expand on the company’s platinum chromium customized stent product portfolio, BSI says, but without the everolimus drug. Rebel, the company claims, has high visibility, low recoil, robust radial strength and is resistant to fracture.

Its low-profile delivery system has a shorter tip that is easier to see, a dual-layer balloon and a bi-segment inner lumen catheter; these facilitate the stent’s placement across difficult lesions.

Rebel comes in 48 sizes, from diameters of 2.25 mm to 4.50 mm and lengths of 8 mm to 32 mm, designed to suit patients’ specific anatomy and runs on the company’s Monorail platform. A single-arm interventional study recently evaluated the safety and efficacy of the OMEGA Monorail system in U.S. and European patients; this study will eventually support BSI’s application for FDA clearance, BSI said. — Lena Freund

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