IRRAS AB, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced the publication of a clinical case report entitled, “Drainage, Irrigation, and Fibrinolytic Therapy (DRIFT) for Adult Intraventricular Hemorrhage Using IRRAflow Self-Irrigating Catheter” in the Cureus Journal of Medical Science.
The publication concluded that the use of IRRAflow is a “safe and effective way to avoid complications related to standard EVD placement, such as clotting and replacement.” Also, it was noted that “our case demonstrates clear radiographic and clinical superiority of the IRRAflow system compared to standard EVD.”
This manuscript reports the use of IRRAflow to treat intraventricular hemorrhage (IVH) for the first time in peer-reviewed literature. In addition, the case report also documents the initial published clinical experience using the IRRAflow system to deliver medication that dissolves blood collected within the ventricles after a hemorrhagic stroke. Previously, targeted delivery of anti-spasm medication using an earlier generation of the IRRAflow system was reported in the Asian Journal of Neurosurgery.
“Documenting the treatment of an IVH with IRRAflow for the first time in a peer-reviewed journal is a meaningful step forward in our efforts to build clinical evidence to support the system’s front-line use,” said Kleanthis G. Xanthopoulos, Ph.D., Chief Executive Officer of IRRAS. “Even more importantly, when a world-leading institution such as Buffalo General Medical Center highlights clearly superior performance of IRRAflow compared to passive drainage techniques, it validates the system’s impact and sets the stage for broadened adoption.”
The corresponding author on the report is Dr. Adnan Siddiqui, MD, Vice Chairman and Professor of Neurosurgery at the State University of New York at Buffalo (UB) Jacobs School of Medicine and Biomedical Sciences. Dr. Siddiqui is also the director of neurosurgical stroke service at Kaleida Health’s Gates Vascular Institute (GVI), director of the neuroendovascular fellowship program at UB, director of the UB Canon Stroke and Vascular Research Center, and the Chief Executive Officer & Chief Medical Officer of the Jacobs Institute (JI), a non-profit medical device innovation center.
Dr. Elad Levy, MD, Chairman of the Department of Neurosurgical Surgery at the UB Jacobs School of Medicine and Biomedical Sciences and Secretary of the Congress of Neurological Surgeons (CNS) Executive Committee, served as a co-author on the case report, along with Dr. Timothy O’Connor, MD, Dr. Ryan Hess, MD, Dr. Asham Khan, MD, and Dr. Kenan Rajjoub, MD.
The case report highlights treatment using the IRRAflow fluid management system for a patient suffering from IVH at Buffalo General Medical Center in Buffalo, NY. IVH is a devastating form of intracranial bleeding “with an expected mortality rate between 50 and 80%,” according to the case report.
During this patient treatment, an IRRAflow catheter was placed into the patient’s right ventricle and provided drainage without interruption throughout patient treatment. A traditional external ventricular drain (EVD) was placed in the patient’s left ventricle, but, “by the following day, the left-sided EVD catheter had become clotted and stopped draining.”
The occluded EVD was subsequently replaced with a second IRRAflow catheter, and the decision was made to deliver a thrombolytic medication, alteplase, through the IRRAflow catheter to dissolve the collected blood. After this decision to convert treatment completely to IRRAflow, follow-up scans clearly showed a decrease in the volume of blood present and the size of the patient’s enlarged ventricles, which was not possible before with an occluded EVD.
“Our long-term strategy is to expand the use of IRRAflow toward targeted drug delivery,” said Will Martin, President and Chief Commercial Officer of IRRAS. “With traditional IV administration, it is difficult for many of these medications to cross into the brain and reach therapeutic levels, but IRRAflow‘s recurring irrigation can potentially offer this capability in a controlled manner. Documenting this early experience in published literature sets the stage for future conversations with regulatory agencies.”