The U.S. Food and Drug Administration (FDA) has cleared a device designed to reduce stroke risk during stent and angioplasty procedures.
The Enroute transcarotid neuroprotection system (TNS), manufactured by Silk Road Medical, is for use during minimally invasive procedures to restore normal blood flow to narrowed carotid arteries. It is designed to access the carotid arteries through an incision in the neck, instead of the groin, and uses a blood-flow reversal system to capture pieces of blockages dislodged during procedures, the company said.
Enroute TNS captures debris by temporarily shunting blood flowing through the narrowed section of the artery away from the brain and into a filtering system outside the body. Blood is then returned to the body though a vein in the leg.
