IRRAS’s Intracranial Bleeding Management Device Used on First U.S. Patient
IRRAS AB, a commercial-stage medical-technology company, today announced that the first patient in the United States was successfully treated with IRRAflow, the company’s initial product that offers an innovative, therapeutic approach to the fluid management of patients with intracranial bleeding.
“The US is the largest market for intracranial procedures, and we are making significant progress engaging neurocritical care centers and specialty hospitals across the country,” said Kleanthis G. Xanthopoulos, Ph.D., President and CEO of IRRAS. “We’re thrilled to see the first patient treated in the United States and remain confident that IRRAflow will dramatically improve the outcomes for many future patients.”
This first IRRAflow patient treatment in the US was performed at the University of California – Irvine (UCI) Medical Center, located in Orange, California. The team, led by UCI Health neurosurgeon Dr. Sumeet Vadera, successfully treated a patient suffering from a chronic subdural hematoma that formed after a recent fall.
“We are excited to be the first site in the United States to use the IRRAflow system,” said Dr. Vadera, Associate Professor of Neurological Surgery, UCI School of Medicine. “At UCI, we pride ourselves on providing our patients the latest in cutting-edge treatment options, and we can now provide the first active, therapeutic treatment to manage intracranial fluid with IRRAflow.”
IRRAflow addresses the complications associated with current passive treatment methods by using a dual lumen catheter that combines active irrigation with ongoing fluid drainage. Since receiving US Food and Drug Administration (FDA) clearance in 2018 to market the system in the United States, IRRAS has taken many needed steps to launch the product, including establishing a customer service and shipping partnership with global logistics specialist, HealthLink Europe & International, hiring Territory Managers, and developing needed marketing and training materials.
See Full Press Release at the Source: First Patient in the United States Successfully Treated With IRRAflow®
Press Release by IRRAS AB
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