This article is more than 5 years old. Information may no longer be current.
FDA Clears Transcarotid Neuroprotection System
Click Here to Manage Email Alerts
The FDA today announced it has cleared for marketing a transcarotid neuroprotection system that could make carotid artery angioplasty and stenting safer.
The transcarotid neuroprotection system (Enroute, Silk Road Medical) is the first device designed to access the carotid arteries through an incision in the neck instead of the groin, and it uses a blood flow reversal system to capture pieces of carotid plaque that could break off during carotid artery angioplasty or stenting, according to an FDA press release.
Operators performing carotid artery stenting typically use a filter or additional balloon to capture and remove pieces of plaque or other debris that could become dislodged and travel to the brain, resulting in stroke, according to the release. The transcarotid neuroprotection system is able to capture the debris by temporarily shunting blood flowing through the affected region of the carotid artery away from the brain and into a filtering system outside the body, and then returns blood to the body via a vein in the leg.
“The Enroute [transcarotid neuroprotection system] provides a minimally invasive treatment for certain patients whose torturous (twisted) or diseased vasculature does not permit access via the groin for treating their narrowed carotid arteries,” William Maisel, MD, MPH, acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, said in the release.