Device Dossier
Advanta V12 Covered Stent System - Prosthesis, internal, stent, vascular - Prosthesis, internal, stent, vascular
Device Dossier for Advanta V12 Covered Stent System - Prosthesis, internal, stent, vascular - Prosthesis, internal, stent, vascular (Peripheral artery…
- GMDN category: Peripheral artery endovascular stent-graft, non-medicated
Intended purpose
The Advanta V12 covered stent system is indicated for use in treating patients diagnosed with renal artery stenosis and/or aortoiliac occlusive disease, including lesions at the aortic bifurcation, when endovascular therapy is required.
Functional description
The device is a balloon-expandable stent, made of 316L stainless steel and encapsulated with expanded PTFE. The delivery system comprises an over-the-wire catheter with a non-compliant balloon. The delivery system is compatible with a 0.035” guidewire and has a useable length of 80cm or 120cm. Two radiopaque marker bands indicate the dilating section of the balloon and aid in stent positioning during fluoroscopy.