IRRAS Announces CE Mark Approval for its Enhanced IRRAflow Dual-Lumen Catheter
Stockholm, October 7, 2021 - IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced the approval for an enhanced IRRAflow dual-lumen catheter in Europe. DEKRA, the company’s notified body, recently approved upgrades to the catheter, which is placed in the intracranial space as part of the IRRAflow system to perform active fluid exchange. This enhanced catheter is already being used commercially in the United States.
IRRAflow, the company’s initial commercial product, is a transformative medical device that offers intracranial fluid exchange by combining controlled irrigation and ongoing fluid drainage to better manage neurocritical care patients. The new IRRAflow 2.0 catheter now incorporates improved kink resistance, which improves catheter deliverability, and an upgraded dual-lumen design that results in optimized irrigation and drainage rates.
“We are pleased to receive CE Mark approval for our enhanced IRRAflow catheter in Europe,” said, Will Martin, President and Chief Executive Officer of IRRAS. “We have received positive feedback from the early clinical experience with this new catheter in the US, and we are excited to offer our growing list of European customers the latest IRRAflow innovations.”
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 is listed on Nasdaq Stockholm (ticker: IRRAS).
For more information, please contact:
President and CEO
Director, Investor Relations
+46 102 11 5172
The information was released for public disclosure, through the agency of the contact person above, on October 7, 2021 at 08:30 (CET).