XIENCE Skypoint Everolimus Eluting Coronary Stent System - Drug-eluting coronary artery stent, non-biodegradable-polymer-coated

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Saatavilla:

Abbott Vascular Division of Abbott Medical Australia Pty Ltd

luokka:

Class III

Valmistaja:

Abbott Medical 3200 Lakeside Drive, Santa Clara, California, 95054 United States Of America

Terapeuttinen alue:

56284 - Drug-eluting coronary artery stent, non-biodegradable-polymer-coated

Käyttöaiheet:

XIENCE Skypoint is a medical device that will deliver and deploy a balloon-expandable, drug-coated 605 stent in de novo and restenotic native arteries to improve coronary artery luminal diameter.The mode of action is mechanical opening of stenosed vessels. The radiopaque balloon markers are used to position the stent in the target lesion. The balloon is then inflated to deploy the stent, followed by withdrawal of the delivery system once stent position and full deployment have been confirmed. The XIENCE Skypoint 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 (two lesions in two different epicardial vessels), lesions residing within small coronary vessels; lesions where treatment results in the jailing of side branches (lesions with a side branch < 2 mm in diameter or an ostial stenosis < 50%); for the treatment of elderly patients (age ? 65), and for treatment of both men and women. ? For treatment of patients with high bleeding risk (HBR) under dual anti-platelet therapy (DAPT) 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 (defined as coronary artery lesions with TIMI flow 0 and lasting longer than 3 months); and coronary artery bifurcation lesions. Additional indication applicable for XIENCE Skypoint ((2.0 ? 4.0 mm, 8.0 - 38 mm) and (4.5 - 5.0 mm, 12 ? 33mm)): ? For the treatment of patients presenting with left main coronary artery lesions. In all cases for ? XIENCE Skypoint ((2.0 ? 4.0 mm, 8.0 - 38 mm) and (4.5 - 5.0 mm, 12 ? 33mm)): the treated lesion length should be less than the nominal stent length (8 mm, 12 mm, 15 mm, 18 mm, 23 mm, 28 mm, 33 mm, or 38 mm) with a reference vessel diameter of ? 2.00 mm and ? 5.25 mm. ? XIENCE Skypoint (2.5 ? 4.0 mm, 48 mm): the treated lesion length should be less than the nominal stent length (48 mm) with a reference vessel diameter of ? 2.50 mm and ? 4.25 mm.

Valtuutuksen tilan:

A

Valtuutus päivämäärä:

2022-08-05