Research & Development
IRRAS wins FDA clearance to expand time of use of IRRAflow
22 November 2019 -

Swedish healthcare company IRRAS AB (STO:IRRAS) reported on Thursday the receipt of US Food and Drug Administration (FDA) 510(K) clearance to expand the time of use of IRRAflow, the world's first irrigating ventricular drain, for the benefit of neurocritical care patients.

IRRAS received initial FDA clearance for IRRAflow in July 2018.

The company said that IRRAflow's unique mechanism of action addresses the complications associated with the current methods of managing intracranial fluid by using a dual lumen catheter that combines active irrigation with ongoing fluid drainage. IRRAflow incorporates intracranial pressure or ICP monitoring and uses a proprietary software to regulate treatment based on desired pressure levels.

According to the company, its new 510(K) application provided the FDA with supporting data demonstrating that extending the time of use of IRRAflow is safe and has the potential to be beneficial for patients.