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Gore Receives 510 (k) Clearance For GORE Flow Reversal System

W. L. Gore & Associates (Gore) announced that the company received 510 (k) clearance to market the GORE Flow Reversal System at the International Congress on Endovascular Interventions XXII. The system uses novel technology that 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. GORE Flow Reversal System uses a novel 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. 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). The 30-day stroke, death, and MI rate was 3.7 percent and the death / any stroke rate was 2.9 percent. Importantly, the study also showed encouraging results in some of the most challenging patient populations with a low death, stroke, and MI rate of 2.6 percent for octogenarians and 3.8 percent for symptomatic patients.