GORE Flow Reversal System Cleared by FDA

Breakthrough System Provides Neuroprotection During Carotid Artery Stenting by Reversing Blood Flow at the Treatment Site and Continuously Directing Emboli Away from the Brain

FLAGSTAFF, Ariz.--(HSMN NewsFeed)--W. L. Gore & Associates (Gore) today announced at the International Congress on Endovascular Interventions XXII the US Food and Drug Administration (FDA) has given the company 510(k) clearance to market the GORE Flow Reversal System. This new technology minimizes the risk of emboli reaching the brain during critical stages of carotid artery stenting (CAS), expanding treatment options for broad patient populations with carotid artery disease.

One of the major challenges associated with CAS is the risk of peri-procedural embolic events that could cause a stroke. The GORE Flow Reversal System is a unique neuroprotection technology that reverses the flow of blood at the treatment site prior to crossing the lesion. Flow reversal is achieved by selectively occluding common carotid and external carotid artery blood flow. By establishing an arterio-venous shunt, blood from collateral vessels via the Circle of Willis is redirected to the lower pressure venous return. Macro and micro emboli are continuously directed away from the brain during flow reversal.

Full text >>