DevicePMAs@therightstef:P970020_S042 JSONTXT 11 Projects

Approval for the multi-link rx and otw zeta coronary stent systems. The devices are indicated for improving coronary lumen diameter in the following: 1) patients with symptomatic ischemic heart disease due to discrete de novo or restenotic native coronary artery lesions (length <= 25 mm) with reference vessel diameters ranging from 3.0 mm to 4.0 mm. 2) patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts (length <= 35 mm) with reference vessel diameters ranging from 3.0 mm to 4.0 mm. 3) restoring coronary flow in patients experiencing acute myocardial infarction, as confirmed by st segment elevation or angiographic findings, who present within 12 hours of symptom onset with native coronary artery lesions of length <= mm with a reference vessel diameter of 2.5 mm to 4.0 mm. 4) treatment of abrupt or threatened abrupt closure in patients with failed interventional therapy in lesions (<= 35 mm in length) with reference vessel diameters ranging from 2.5 mm to 4.0 mm. Long-term outcome for this permanent implant is unknown at present.