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Boston Scientific Nets Approvals for DCBs, BMS and New TAVR Valve Size
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Boston Scientific has received CE marks for its Ranger and Agent drug-coated balloons and 25-mm Lotus transcatheter valve system and an FDA approval for its Rebel platinum chromium coronary stent system. The company also received both FDA 510(k) clearance and a CE mark for its Polaris imaging system.
According to a press release, the Ranger paclitaxel-coated PTA balloon catheter is intended to treat peripheral artery disease, whereas the Agent paclitaxel-coated PTCA balloon catheter is indicated for the treatment of both in-stent restenosis and de novo small vessel coronary disease. The devices feature the TransPax coating technology designed to maintain drug-coating integrity and maximize drug-transfer efficiency.
An additional CE mark was granted to the company’s new 25-mm Lotus transcatheter aortic valve replacement system, which joins the currently available 23-mm and 27-mm valve sizes.
In the United States, Boston Scientific received FDA approval for its Rebel platinum chromium coronary stent system, following the receipt of the CE mark in February. Rebel is the company’s latest-generation bare-metal stent and features the same stent platform as the Promus Premier drug-eluting stent, but without the everolimus drug. It is intended for the treatment of CAD and comes in 46 sizes, ranging from 2.25 mm to 4.5 mm and lengths of 8 mm to 32 mm on a Monorail platform, according to the release.
In other regulatory news, Boston Scientific’s Polaris imaging system received FDA 510(k) clearance and a CE mark. The system includes enhanced ease-of-use and more powerful processing capabilities and will join the company’s family of IVUS catheters, the company stated in the release.