The device, which received CE Mark in June 2015 and FDA clearance in March 2018, is a distal
embolic protection filter used to capture debris that can be associated with all types of peripheral vascular intervention procedures.
The CE Mark and FDA approved WIRION Embolic Protection System device is a distal
embolic protection filter used to capture debris that can be associated with all types of peripheral vascular intervention (PVI) procedures.
Recommended Usage: Self-expanding nitinol stent, used with an
embolic protection filter to capture emboli during the stenting procedure.
* Recommended Usage: Self-expanding nitinol stent, used with an
embolic protection filter (the Emboshield Embolic Protection System) to capture emboli during the stenting procedure.
It allows the physician to adjust the size of the
embolic protection filter in vivo to suit each individual patient's anatomy.
During 1 year of follow-up, patients who were treated with this stent along with the
embolic protection filter had a 9.1% incidence of major adverse events, showing that the stent was not inferior to carotid endarterectomy using historic controls, Christopher J.
This
embolic protection filter system provides protection from blood clots and emboli produced during catheterization procedures for the opening of blocked blood vessels.
An adjunct to this technique is the use of
embolic protection filters to reduce risk of stroke from emboli being produced during placement of the valve.
Moreover other minimal invasive devices such as embolic protection filters, stented valves, etc are rapidly entering clinical practice.
Consequently, embolic protection filters have been developed to capture this released debris and they appear to have a significant favorable impact on the CAS outcomes (Yen, 2005 and Goodney, 2006).
