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).