IRRAS receives new US FDA 510(k) clearance for next-generation IRRAflow control unit

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IRRAS has announced that it recently received regulatory clearance from the US Food and Drug Administration (FDA) to activate all of the functionality on the next-generation control unit for its flagship product, IRRAflow—which it claims is the world’s first and only active fluid exchange system.

Earlier this year, IRRAS introduced this next-generation IRRAflow system, which included embedded interactive tutorials, intuitive software with upgraded graphics, refined treatment workflow, and a new drainage collection design, to its customers in the USA. This most recent FDA 510(k) clearance extends the system’s previous FDA clearances, and permits the activation of software functionality that connects to the patient’s bedside monitor and openly transmits treatment information to the central nursing station.

The IRRAflow system advances treatment options for patients suffering from intracranial bleeding as the first irrigating drainage system that enables active fluid exchange, according to an IRRAS press release. IRRAflow combines automated irrigation, controlled drainage, and continuous monitoring of the patient’s intracranial pressure, into one intelligent system. Its unique mechanism of action uses recurring irrigation to prevent solid particles from blocking the drainage holes on the catheter tip and to also dilute collected toxic material, making it easier to remove.

“IRRAS prides itself on consistently upgrading its products to better meet the needs of its customers, and the US regulatory clearance of the next-generation IRRAflow control unit is the latest example of our team delivering upon that promise,” said Will Martin, president and CEO of IRRAS. “Our team remains focused upon incorporating customer feedback into our technologies to enhance the user experience and optimise care for their critically ill patients. Being able to introduce the latest IRRAflow functionality is the exciting next step toward accomplishing our mission to becoming a global leader in the neurocritical space.”


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