Gore Flow Reversal System cleared by the FDA


Gore announced at the International Congress on Endovascular Interventions, in Phoenix, Arizona, USA, that the FDA has given the company 510(k) clearance to market the Gore Flow Reversal System. This new technology minimises the risk of emboli reaching the brain during critical stages of carotid artery stenting, expanding treatment options for broad patient populations with carotid artery disease.

The system is a 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.

Dr Daniel G. Clair, Cleveland Clinic Foundation and national co-principal investigator for the Gore EMPiRE clinical study said, “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 EMPiRE study, the safety and efficacy of the system during CAS was assessed in patients at high risk for carotid endarterectomy. The study met the primary endpoint of major adverse events of death, stroke, transient ischemic attack, and myocardial infarction. The 30-day stroke, death, and infarction rate was 3.7% and the death/any stroke rate was 2.9%. Importantly, the study also showed encouraging results in some of the most challenging patient populations with a low death, stroke, and heart attack rate of 2.6% for octogenarians and 3.8% for symptomatic patients.

“The results from the Gore EMPiRE clinical study are extremely promising as we strive to better protect patients and demonstrate the value of carotid artery stenting in the treatment of carotid disease. This is one of the first carotid artery stenting studies to report rates within the American Heart Association guidelines for carotid endarterectomy,” stated Dr L Nelson Hopkins, University of Buffalo and national co-principal investigator. “We are optimistic that evolving technologies, such as the Gore Flow Reversal System, will enable carotid artery stenting to become the therapy of choice in the treatment of carotid disease.”