DevicePMAs@therightstef:P980001_S000 JSONTXT

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The device is indicated for improving coronary luminal diamter in the following patient subsets: a) patients with symptomatic ischemic disease due to discrete de novo lesions in native coronary arteries (length \u003c25 mm) with a reference vessel diameter of 3.0 to 4.0 mm; b) treatment of abrupt or threatened closure in patients with failed interventional therapy in lesions with reference diameters in the range of 2.5 to 4.0 mm; c) patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts with lesion length \u003c 30 mm and reference vessel diamter in the range of 3.0 to 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