IRRASS Receives Further 510(k) Clearance for Irrigating Ventricular Drain

IRRASS received an additional 510(k) clearance to expand the time of use of its IRRAflow  irrigating ventricular drain, used for drainage of intracranial bleeding.

IRRAflow uses a dual lumen catheter that combines active irrigation with ongoing fluid drainage. The catheter enables intracranial pressure monitoring and uses proprietary software to regulate treatment based on desired pressure levels.

IRRAS received initial clearance from the FDA for IRRAflow in July 2018.