Device Dossier
Filterwire EZ Embolic Protection System - Catheter, embolectomy
Device Dossier for Filterwire EZ Embolic Protection System - Catheter, embolectomy (Catheter, embolectomy, Class III, sponsor Boston Scientific). ARTG…
- GMDN category: Catheter, embolectomy
Intended purpose
The FilterWire EZ Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in the peripheral vascular system, carotid arteries, coronary arteries and saphenous vein grafts.
Functional description
FilterWire EZ Embolic Protection System is a percutaneous guide wire filtration system. The filter is positioned distal to the lesion & the delivery sheath is withdrawn to deploy the filter, which is designed to contain & remove embolic material. The protection wire serves as the rail over which other catheters & instruments are advanced to the target lesion. At the end of the procedure, the filter is captured using the retrieval sheath & the system is withdrawn.