www.fdanews.com/articles/192305-perfuze-snags-breakthrough-designation-for-clot-removal-device
Perfuze Snags Breakthrough Designation for Clot Removal Device
August 9, 2019
The FDA has granted Perfuze breakthrough device designation for its Millipede CIS technology, a catheter device that removes clots in the brain following an acute ischemic stroke.
Ischemic strokes happen when blood flow in the brain is blocked by a blood clot. The World Health Organization said that stroke is the second leading global cause of death and a leading cause of disability.
The company said it was given the breakthrough device designation due to the clot removal device’s potential advantages over existing AIS treatments.