IRRAS Receives Renewed CE Mark for IRRAflow Catheter

IRRAS, a global healthcare company with a portfolio of products for neurocritical care, has received CE Mark approval for its IRRAflow catheter. This CE mark complements the two CE marks previously obtained for the IRRAflow system’s tube set with digital pump and control unit, and allows IRRAS to once again commercially market the IRRAflow system in the European Union. The complete IRRAflow CNS System received approval for CE mark and will be ready for commercial launch in the European Union.  
 
IRRAflow, the company’s initial commercial product, is a transformative medical device system that combines controlled irrigation with ongoing fluid drainage to better manage patients with intracranial bleedings. In April 2018, IRRAS received an updated ISO 13485:2016 certificate and updated CE mark approvals for both the control unit and tube set with digital pump in the IRRAflow system, both of which are Class II products. The proprietary IRRAflow catheter, however, is a Class III product, and required more time to review.  
 
“We are pleased to receive the final CE mark for IRRAflow in Europe, which is a strategically important geography for IRRAS,” said Kleanthis G. Xanthopoulos, Ph.D., president and CEO of 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.” 
 
“In my previous patient treatment experience with IRRAflow, I found the system’s combination of irrigation and drainage to be a valuable tool in treating my critically ill patients with intracranial bleeding and brain infections,” said Dr. Behnam Rezai Jahromi, neurosurgeon from Helsinki University Hospital in Helsinki, Finland. “Innovation in neurocritical care has been limited through the years, and I look forward to studying the potential impact of IRRAflow more closely in the future.” 
 
The system was designed to prevent obstructions in the catheter tubing, which when occurs with current catheters must be removed and replaced in an invasive procedure. Furthermore, by continuously irrigating the brain’s fluid cavities, any blood or infection nidus may be cleared faster and therefore, as the company believes, the catheters would be able to be removed faster.
 
“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,” said Will Martin, IRRAS’ chief commercial officer. “Based on this early experience, we are confident that IRRAflow will continue to significantly improve patient outcomes and result in sustained sales growth.”   
 
The IRRAflow system received 510(k) clearance from the U.S. Food and Drug Administration in July 2018. It is currently cleared for saline irrigation, but the catheter may in the future be used for infusion of pharmacological agents, such as antimicrobial, antithrombotic, or even anticancer medications.