New Device Cleared to Reduce Stroke Risk
First approved device designed to enter artery through neck, not groin
MONDAY, Feb. 9, 2015 (HealthDay News) -- The ENROUTE Transcarotid Neuroprotection System has been approved by the U.S. Food and Drug Administration as a minimally invasive device designed to help prevent stroke.
The device is the first one designed to access one of two major arteries on the side of the neck -- the carotid arteries -- via the neck instead of the groin, the FDA said Monday in a news release. It uses a "blood flow reversal system" to capture pieces of a blockage that could otherwise travel to the brain and cause a stroke.
Blockages in one or both carotid arties are commonly caused by cholesterol or fatty deposits, narrowing these vessels and causing carotid artery disease. More than half of all strokes in the United States are caused by this process, the FDA said, citing the National Heart Lung and Blood Institute. A person with carotid artery disease may not have symptoms until the onset of stroke, the FDA said.
If carotid artery disease it severe enough, it may require a surgeon to perform a balloon angioplasty, in which a balloon at the end of a long flexible tube is inflated to clear the blocked artery. The ENROUTE system is used during the procedure to remove debris that may have dislodged from the blockage and could otherwise travel to the brain.
Clinical studies showed the new device was effective in preventing cases of stroke, heart attack and death, the FDA said. Serious adverse reactions, however, included excessive bleeding at the access site, low blood pressure, and blood clot formation during post-angioplasty surgery to implant a stent -- a hollow tube designed to prop open the formerly-clogged artery.
The ENROUTE system is produced by Silk Road Medical, based in Sunnyvale, Calif.
The FDA has more about this approval.