Everolimus-Eluting Coronary Artery Stent
Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Abbott Medical·Registered Nov 14, 2024- Analysis ID
- 2403501ĐKLH/BYT-HTTB
- Submission ID
- 17001924/ĐKLH-BYT-TB-CT
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Abbott Medical
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Abbott Medical
- Authorized Representative
- VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI
- Intended Use
- The Everolimus-coated XIENCE Alpine™ coronary stent system is indicated to improve the luminal diameter of the coronary arteries in the following cases: • Patients with symptomatic coronary artery disease (CAD) due to de novo, separate, native coronary artery lesions. • To restore coronary blood flow in patients with acute myocardial infarction (AMI) who present within 12 hours of symptom onset. • To treat patients with concomitant diabetes, acute coronary syndrome (ACS), double vessel disease (two different lesions in the two main coronary arteries), lesions in the smaller coronary arteries; lesions that would result in the retention of branch vessels (lesions of branch vessels with a diameter < 2 mm or severely calcified < 50%); to treat elderly patients (age ≥ 65 years), and to treat both men and women. • To treat patients at high risk of bleeding (High Bleeding Risk, HBR) according to dual antiplatelet therapy (DAPT) for a minimum duration of 28 days. • To treat patients with in-stent restenosis in coronary artery lesions; chronic total occlusions of the coronary arteries (determined as a coronary artery lesion with a TIMI flow of 0 and lasting more than 3 months); and coronary artery bifurcation lesions. In all cases, the length of the lesion to be treated must be less than the designated length of the stent (8 mm, 12 mm, 15 mm, 18 mm, 23 mm, 28 mm, 33 mm, or 38 mm) with a reference vessel diameter ≥ 2.00 mm and ≤ 4.25 mm.
- Registration Date
- Nov 14, 2024
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Access comprehensive regulatory information for Everolimus-Eluting Coronary Artery Stent in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2403501ĐKLH/BYT-HTTB and manufactured by Abbott Medical. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI.
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