Swedish medical device company IRRAS is attempting to change the way neurosurgeons and neurointensivists handle the problem of acute hydrocephalus. Hydrocephalus is the abnormal accumulation of cerebrospinal fluid (CSF) in the brain, and is often caused by hemorrhage, tumor, infection, or traumatic brain injury. Traditionally, surgeons use an external ventricular drain (EVD) catheter, that is placed into the brain’s fluid spaces to drain the excess CSF. However, current ventricular catheter technology is limited to passive draining of fluid, and catheter obstructions are not uncommon.
IRRAS’ first commercial product, IRRAflow, consists of a dual-lumen ventricular drainage catheter that allows for simultaneous irrigation and drainage of the brain’s fluid spaces. The system is connected to a digital intracranial pressure monitor, which regulates irrigation rate and volume for more precise control.
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.
The IRRAflow system was 510(k) cleared in July 2018 by the US FDA for use in patients with hydrocephalus. While it is currently cleared for saline irrigation, the catheter may in the future be used for infusion of pharmacological agents, such as antimicrobial, antithrombotic, or even anticancer medications.
IRRAS is headquartered in Stockholm, Sweden, with offices in Munich, Germany, and San Diego, CA. It was founded in 2011, and underwent IPO in 2017 in Sweden.
Here’s a promo video presenting the IRRAflow system:
Link: IRRAS homepage…