Meeting The Occlusion Challenge
IRRAS believes that our proprietary technology and innovation for the treatment of hemorrhagic stroke and other CNS pathologies will establish the IRRAflow™ device as the market leader for minimally invasive neurosurgical procedures and therapies. Our primary clinical strategy is to provide a significantly improved solution for stroke and hematoma patients with less invasiveness and more efficacy, through the integration of aspiration, targeted infusion and intracranial pressure monitoring in a single robust device. We believe IRRAflow™ has clear benefits and will demonstrate improved patient outcomes in comparison to the treatment options and devices that are currently on the market. We continue to develop additional features for the IRRAflow™ device to more effectively address these and other unmet challenges for the treatment of CNS pathologies.
Problem: EVD Blockage
Most external ventricle drainage (EVD) systems on the market today are relatively simple in design achieving gravity-driven aspiration. They consist of an intracranial catheter, which evacuates blood and pathological collections to an aspiration bag attached to a bedside pole. The aspiration rate is controlled by changing the height of the aspiration bag in respect to the tip of the catheter inside the patient’s head.
All current drainage systems have a significant risk of catheter blockage when coagulated blood and other particles reach the catheter (for example intra-ventricular hemorrhage blocks the drainage catheters in minutes or hours after insertion). This occurs in more than 30% of the cases. Blockage of the catheter can lead to severe deterioration of the patient’s neurological status and even death, due to ICP elevation. Unless the blockage is removed, an immediate operation for removal of the blocked catheter and positioning of a new one must take place which is associated with potential contamination, inconvenience and mortality risks. In addition to these risks, the additional time and personnel required to change to a new catheter is a substantial financial burden to health care providers.
IRRAS Dynamic Intelligent Fluid Exchange – The Solution For EVD Blockage
The IRRAflow™ system is a transformational device that addresses the significant rates of morbidity and mortality relating to the inadequate monitoring and management of intracranial pressure and CSF drainage. It is not only a pressure monitoring device, but also as a treatment modality allowing CSF drainage to lower intracranial pressure. Unlike existing practices and devices, which have the potential for blockage, the IRRAflow™ system is not susceptible to blockage.
IRRAflow™ clinical superiority is achieved by the periodic infusion of physiological fluid to the intracranial catheter, which keeps the holes of the catheter tip unobstructed, ensuring the accuracy of the pressure measurement and the patency of the drainage.
The cyclical function of the intelligent system, including infusion, pressure measurement and aspiration times ensures continuous and consistent intracranial pressure management which is the most significant factor in a positive patient outcome. Through clinical trials we seek to prove the therapeutic superiority of the IRRAflow™ system and continually expand its utility by adding new features and therapeutic applications.