Device Dossier
Epic™ Over-the-wire Self-Expanding Nitinol Vascular Stent with Delivery System - Multiple peripheral arteries stent
Device Dossier for Epic™ Over-the-wire Self-Expanding Nitinol Vascular Stent with Delivery System - Multiple peripheral arteries stent (Multiple…
- GMDN category: Multiple peripheral arteries stent
Intended purpose
The Epic™ Over-the-wire Self-Expanding Nitinol Vascular Stent with Delivery System is indicated to improve luminal diameter in the treatment of adults with de-novo or restenotic lesions in the iliac arteries, superficial femoral artery (SFA), and/or proximal popliteal artery (PPA).
Functional description
Epic Stent System consists of the implantable endoprosthesis (stent) and the stent delivery system. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy (nitinol). On both the proximal and distal ends of the stent, radiopaque tantalum markers increase visibility of the stent to aid in placement. The Epic Stent is constrained by the delivery system prior to deployment and is deployed by retracting the exterior shaft of the delivery system.