DIVE Trial of IRRAflow System to Treat Intraventricular Hemorrhage Begins Enrollment

August 23, 2022—IRRAS, a Stockholm, Sweden–based medical technology company focused on neurocritical care, announced the initial patient treatments with the company’s IRRAflow system as part of the company’s DIVE clinical trial.

According to the company, the DIVE study will assess the IRRAflow system’s ability to treat patients experiencing intraventricular hemorrhage (IVH) more effectively than traditional treatment with an external ventricular drain (EVD). The retrospective and prospective cohort, controlled, single-center, phase 1 study’s primary objective is to evaluate the safety and radiographic outcomes associated with using the IRRAflow system compared to the current standard of care with EVDs.

The first two patients with IVH were enrolled in the DIVE trial within the Mount Sinai Health System in New York, New York. Investigators will compare retrospective EVD data from Mount Sinai Hospital and Mount Sinai West Hospital to prospective data collected from future patients treated with IRRAflow in up to 140 patients (70 EVD vs 70 IRRAflow).

Christopher Kellner, MD, who is Assistant Professor of Neurosurgery and Director of the Intracerebral Hemorrhage program at Mount Sinai, serves as the Principal Investigator of the study and enrolled the first two patients.

“We are excited to enroll our first patients in the DIVE study,” commented Dr. Kellner in the company’s press release. “We believe that the combination of irrigation and drainage has the potential to be a more efficient and cost-effective means to treat IVH than traditional passive drainage.”

Dr. Kellner added, “Our first patient was successfully treated in just 67 hours, a significant reduction from our historic data for [intensive care unit] and hospital length of stay. This study will continue to enroll patients and assess outcomes.”