IRRAS Announces Extension of CE Mark for IRRAflow System until May 2024
- European Union regulatory approval in place for IRRAflow Control Unit, Tube Sets, and Single-use Catheters until May 2024
- Extension of CE Mark expiration date ensures commercial availability of IRRAflow system without interruption during the European Union’s transition to new MDR regulatory standards
Stockholm, July 22, 2020 – IRRAS AB, a commercial stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced the extension of the CE Mark until May 2024 for all components of its IRRAflow system, including the IRRAflow control unit, disposable Tube Set with digital pump, and both versions of the IRRAflow dual-lumen drainage catheter.
"The extension of our CE Mark for IRRAflow is not only an important milestone for our company, but it also reinforces the need for innovative solutions for patients with intracranial bleeding," said Kleanthis G. Xanthopoulos, Ph.D., CEO of IRRAS. "Each year, 75% of hemorrhagic strokes result in death or disability, and this extension ensures that physicians will continue to have a next generation, intelligent option for these critically ill patients.”
The CE Mark is issued by the European Commission and allows the IRRAflow CNS system to be marketed throughout the EU member nations for the external drainage of intracranial fluid and the measurement of intracranial pressure (ICP) as a means of reducing intracranial pressure. IRRAS received its initial CE Mark in 2014, and the system’s CE Mark recertification was completed in December 2019. This extension of the system’s CE Mark certificate until May 2024 under existing Medical Device Directive (MDD) standards ensures that the IRRAflow will remain commercially available without interruption as the European Union transitions to the new Medical Devices Regulation standards, which is scheduled to occur in May 2021.
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. The system’s automated use of irrigation addresses challenges associated with traditional passive fluid drainage, such as catheter blockages and infection. In addition, IRRAflow’s irrigating fluid helps to dilute toxic material, such as blood or bacteria, that is collected within the intracranial space and make it easier to remove.
“We’re quite pleased to finalize the extension of the CE Mark for IRRAflow until 2024. The regulatory environment in Europe is evolving with the transition to the new MDR standards, and this extension removes any associated regulatory risk for IRRAflow for several years,” said Will Martin, President and Chief Commercial Officer of IRRAS. “Our commercial activities are returning to normal after the covid-19 lockdowns, and this news will permit us to continue our commercial acceleration throughout the second half of 2020 and beyond.”
IRRAS is a global medical care company focused on delivering innovative medical solutions to improve the lives of critically ill patients. IRRAS designs, develops, and commercializes neurocritical care products that transform patient outcomes and decrease the overall cost of care by addressing complications associated with current treatment methodologies. IRRAS markets and sells its comprehensive, innovative IRRAflow and Hummingbird ICP Monitoring product lines to hospitals worldwide through its direct sales organization in the United States and select European countries as well as an international network of distribution partners. IRRAS maintains its headquarters in Stockholm, Sweden, with corporate offices in Munich, Germany, and San Diego, California, USA. For more information, please visit www.irras.com.
IRRAS AB (publ) is listed on Nasdaq Stockholm (ticker: IRRAS).
For more information, please contact:
Kleanthis G. Xanthopoulos, Ph.D.
+46 73 951 95 02
The information was released for public disclosure, through the agency of the contact person above, on July 22, 2020 at 09:45 (CET).