Rapid Medical has received the FDA’s Breakthrough Device designation for its Comaneci embolization assist device for the treatment of cerebral vasospasm following hemorrhagic stroke.

The device temporarily expands blood vessels while allowing physicians to monitor the expansion, apply incremental adjustments and enhance treatment with combination therapeutics.  

In a 30-patient retrospective analysis of the device’s use, 97 percent of patients showed an increase in vessel opening of at least 25 percent, with 80 percent of patients showing an increase of 50 percent or more.

Comaneci is the first device to provide combination therapy to the brain with an adjustable diameter/radial force that may lower the risk of vessel injury, the company said.