DevicePMAs@therightstef:P100023_S015 JSONTXT 11 Projects

Approval to expand the labeled indications for the ion paclitaxel-eluting coronary stent system (monorail and over-the-wire). The ion stent system is indicated for improving luminal diameter: 1) for the treatment of de novo lesions in native coronary arteries 2.25 mm to 4.00 mm in diameter in lesions <= 34 mm in length; or 2) in patients undergoing primary angioplasty to treat acute st-segment elevation myocardial infarction, true posterior myocardial infarction, or presumed new left bundle branch block with symptoms of acute myocardial infarction lasting > 20 minutes and > 12 hours in duration.