Sam Brusco, Associate Editor12.12.22
Neurocritical care company IRRAS has gained U.S. Food and Drug Administration (FDA) 510(k) clearance to activate all functionality on the next-gen control unit for its flagship IRRAflow active fluid exchange system.
IRRAS introduced the next-gen IRRAflow system earlier this year. It included embedded interactive tutorials, software with upgraded graphics, refined treatment workflow, and new drainage collection design. This most recent FDA nod permits activation of software functionality that connects to the bedside monitor and openly transmits treatment info to the central nursing station.
IRRAflow advances treatment options for intracranial bleeding patients as the first irrigating drainage system (according to the company) that enables active fluid exchange. IRRAflow combines automated irrigation, controlled drainage, and continuous intracranial pressure (ICP) monitoring.
Its mechanism of action uses recurring irrigation to prevent solid particles from blocking drainage holes on the catheter tip and dilute collected toxic material. This all makes 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," Will Martin, president and CEO of IRRAS told the press. "Our team remains focused upon incorporating customer feedback into our technologies to enhance the user experience and optimize 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."
IRRAS introduced the next-gen IRRAflow system earlier this year. It included embedded interactive tutorials, software with upgraded graphics, refined treatment workflow, and new drainage collection design. This most recent FDA nod permits activation of software functionality that connects to the bedside monitor and openly transmits treatment info to the central nursing station.
IRRAflow advances treatment options for intracranial bleeding patients as the first irrigating drainage system (according to the company) that enables active fluid exchange. IRRAflow combines automated irrigation, controlled drainage, and continuous intracranial pressure (ICP) monitoring.
Its mechanism of action uses recurring irrigation to prevent solid particles from blocking drainage holes on the catheter tip and dilute collected toxic material. This all makes 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," Will Martin, president and CEO of IRRAS told the press. "Our team remains focused upon incorporating customer feedback into our technologies to enhance the user experience and optimize 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."