CDSCO UID IMP/MD/2023/000509_3ed09f4bb06396c9d0a1c56602341eb0_4d91cbe3666f623b019bcc007a424d1c

Drug Eluting Stents

Abbott Healthcare Private Limited·Device Class Class D·India CDSCO·Brand: Xience Alpine™ Everolimus Eluting Coronary Stent System

Registration details

UID: IMP/MD/2023/000509_3ed09f4bb06396c9d0a1c56602341eb0_4d91cbe3666f623b019bcc007a424d1c
Device class: Class D
Brand name: Xience Alpine™ Everolimus Eluting Coronary Stent System
License holder: Abbott Healthcare Private Limited
Approving authority: CDSCO
Product information: The XIENCE Xpedition™ and Xpedition™ 48 Everolimus Eluting Coronary Stent System is indicated for improving coronary artery luminal diameter in the following: • Patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. • For restoring coronary flow in patients experiencing acute myocardial infarction who present within 12 hours of symptom onset. • For the treatment of patients with concomitant diabetes, acute coronary syndrome, dual vessel lesions (Xience Alpine™ Everolimus Eluting Coronary Stent System), lesions residing within small coronary vessels; lesions where treatment results in the jailing of side branches (Xience Alpine™ Everolimus Eluting Coronary Stent System); for the treatment of elderly patients (Xience Alpine™ Everolimus Eluting Coronary Stent System), and for treatment of both men and women. • For treatment of patients with high bleeding risk (Xience Alpine™ Everolimus Eluting Coronary Stent System) under dual antiplatelet therapy (Xience Alpine™ Everolimus Eluting Coronary Stent System) as short as 28 days. • For the treatment of patients presenting with in-stent restenosis in coronary artery lesions; chronic total occluded coronary artery lesions (Xience Alpine™ Everolimus Eluting Coronary Stent System); and coronary artery bifurcation lesions. Xience Xpedition - In all cases, the treated lesion length should be less than the nominal stent length (Xience Alpine™ Everolimus Eluting Coronary Stent System) with a reference vessel diameter of ≥ 2.00 mm and ≤ 4.25 mm. Xience Xpedition 48 - In all cases, the treated lesion length should be less than the nominal stent length (Xience Alpine™ Everolimus Eluting Coronary Stent System) with a reference vessel diameter of ≥ 2.50 mm and ≤ 3.75 mm