Swedish medical technology firm IRRAS has received CE Mark approval for its IRRAflow catheter, a Class III medical device product and part of the IRRAflow system.
IRRAS has developed the IRRAflow system using an advanced fluid management technology to integrate the controlled irrigation with continuous fluid drainage, for managing the intracranial bleedings.
IRRAS president and CEO Kleanthis G Xanthopoulos said: “We are pleased to receive the final CE Mark for IRRAflow in Europe, which is a strategically important geography for IRRAS. With this approval, we can now ramp up our marketing and sales efforts for the initiation of product sales in the key EU market.”
IRRAflow system is the first commercial product of IRRAS
The IRRAflow system is designed to have a central control unit and disposables, including a dual-lumen catheter, tube set, and digital pump.
The control unit and tube set with digital pump for the IRRAflow system were granted updated CE Mark approvals in April 2018.
The company claimed that its IRRAflow system offers a controlled fluid exchange system, and enables neurosurgeons to actively manage intracranial pressure and CSF drainage.
In addition, it is equipped with fluid exchange technology, monitoring and measuring system for intracranial pressure, a safety alarm to maintain the optimum pressure, and periodic flush irrigation to prevent the blockage of the catheter and associated surgical complications.
IRRAS said that that the CE Mark approval facilitates the marketing of its IRRAflow system in the European Union (EU), following the commercial launch.
IRRAS Chief Commercial Officer Will Martin said: “Over the past year, we have seen many successful case outcomes and significant customer interest across a variety of neurosurgery procedures with IRRAflow, therefore, we are thrilled to be able to continue our expansion to Europe.
“Based on this early experience, we are confident that IRRAflow will continue to significantly improve patient outcomes and result in sustained sales growth.”
