Gore wins FDA approval for its new neuroprotection technology

According to the company, 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 new 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, the company said.

Stuart Broyles, stroke interventions business unit leader at Gore, said: “Gore is pleased to provide the clinical and patient communities with an unsurpassed neuroprotection option for CAS procedures. The Gore Flow Reversal System is an important breakthrough for carotid disease therapy and a key part of Gore’s long-term commitment to carotid stenting and stroke interventions.

“Gore is conducting other studies in the area of stroke intervention including the Gore Reduce clinical study evaluating the Gore Helex Septal Occluder for patent foramen ovale closure and stroke prevention, and the Gore Embolden clinical study evaluating the Gore Embolic Filter in CAS.”