Headframe

The Headframe (product code OVC) is a device intended to enhance mechanical thrombus dissolution and acceleration of thrombolysis in patients suffering acute ischemic stroke. The device is unclassified by the FDA, having gone through a regulatory pathway that did not result in a standard classification; it is GMP exempt and listed as FDA Not Classified with unclassified reason code 3 (indicating it went through a de novo or similar process). It is reviewed by the Neurology panel and has no associated regulation number or medical specialty designation. The device is not an implant and is not life-sustaining.