GORE Flow Reversal System Cleared by FDA

Gore Medical announced today, February 9th 2009, that the US Food and Drug Administration (FDA) has given the company 510(k) clearance to market its Carotid Flow Reversal System.

 Gore Flow Reversal System

The device achieves flow reversal by selectively occluding common carotid and external carotid artery blood flow and 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.

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.

The 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.

FDA approval of the GORE Flow Reversal System was based or results from the Gore EMPiRE Clinical Study. The study evaluated the safety and efficacy of the GORE Flow Reversal System during CAS in patients at high risk for carotid endarterectomy.