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Medical Devices / Submissions and Approvals

Perfuze Snags Breakthrough Designation for Clot Removal Device

Aug. 12, 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.

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