Coronary Stent System - India CDSCO Medical Device Registration

Product Information

Multi-Link 8, Multi-Link 8 SV, and Multi-Link 8 LL Coronary Stent Systems are indicated for improving coronary luminal diameter in the following: Multi-Link 8: Patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions (Xience Prime , Xience Prime SV and Xience Prime LL Everolimus Eluting Coronary Stent System) with reference vessel diameters from 2.5 mm to 4.0 mm. Restoring coronary flow in patients experiencing acute myocardial infarction, who within 12 hours of symptom onset present with native coronary artery lesions (Xience Prime , Xience Prime SV and Xience Prime LL Everolimus Eluting Coronary Stent System) with reference vessel diameters from 2.5 mm to 4.0 mm. Patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts (Xience Prime , Xience Prime SV and Xience Prime LL Everolimus Eluting Coronary Stent System) with reference vessel diameters from 3.0 mm to 4.0 mm. Multi-Link 8 SV: Patients with abrupt or threatened abrupt closure with failed interventional therapy of de novo and restenotic native coronary artery lesions (Xience Prime , Xience Prime SV and Xience Prime LL Everolimus Eluting Coronary Stent System) with reference vessel diameters from 2.0 mm to 2.5 mm. Patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions (Xience Prime , Xience Prime SV and Xience Prime LL Everolimus Eluting Coronary Stent System) with reference vessel diameters from 2.25 mm to 2.5 mm. Multi-Link 8 LL: Patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions (Xience Prime , Xience Prime SV and Xience Prime LL Everolimus Eluting Coronary Stent System) with reference vessel diameters from 2.5 mm to 4.0 mm. Restoring coronary flow in patients experiencing acute myocardial infarction, who within 12 hours of symptom onset present with native coronary artery lesions (Xience Prime , Xience Prime SV and Xience Prime LL Everolimus Eluting Coronary Stent System) with reference vessel diameters from 2.5 mm to 4.0 mm. Patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts (Xience Prime , Xience Prime SV and Xience Prime LL Everolimus Eluting Coronary Stent System) with reference vessel diameters from 3.0 mm to 4.0 mm