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This article was originally published in The Gray Sheet
Executive Summary
Stent for treatment of small coronary vessels will debut in U.S. later this month in diameters of 2.0 mm, 2.25 mm and 2.5 mm. FDA approval via PMA supplement, announced July 9, allows use for abrupt or threatened closure due to unsuccessful interventional therapy in de novo and restenotic native coronary artery lesions. Device was launched in Europe earlier this year