IRRAS this week said it won CE mark approval for its IRRAflow catheter.
The new approval comes after the company received two CE marks for its IRRAflow system’s tube set with a digital pump and control unit.
“We are pleased to receive the final CE mark for IRRAflow in Europe, which is a strategically important geography for IRRAS,” president and CEO Kleanthis Xanthopoulos said in a news release. “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 is a medical device system that uses controlled irrigation with ongoing fluid drainage to manage patients with intracranial bleedings.
“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,” chief commercial officer Will Martin said. “based on this early experience, we are confident that IRRAflow will continue to significantly improve patient outcomes and result in sustained sales growth.”