W. L. Gore & Associates (Gore) 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.

Daniel G. Clair, MD, FACS, of the Cleveland Clinic Foundation and national co-principal investigator for the Gore EMPiRE Clinical Study* stated, "The GORE Flow Reversal System is not only a significant advancement in neuroprotection, it is an important step forward for carotid stenting that may help establish carotid stenting as the therapy of choice for a greater number of patients."

In the Gore EMPiRE Clinical Study, the safety and efficacy of the GORE Flow Reversal System during CAS was assessed in patients at high risk for carotid endarterectomy. The Gore EMPiRE Clinical Study met the primary endpoint of major adverse events of death, stroke, transient ischemic attack (TIA), and myocardial infarction (MI)…