Medical Device News Magazine

Thursday, March 30, 2023

IRRAS Announces First Patient Treatments at Mount Sinai Health System in New York as Part of the DIVE Study

IRRAS, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced the initial patient treatments with the company’s IRRAflow system within Mount Sinai Health System in New York, NY, one of the United States’ largest and most respected hospital groups.

Thus far, two patients suffering from intraventricular hemorrhage (IVH) have been enrolled in the Deployment of Irrigating Intraventricular Catheter System (DIVE) clinical trial for patients. The DIVE study will assess the IRRAflow system’s ability to more effectively treat patients experiencing IVH than traditional treatment with an external ventricular drain (EVD).

The DIVE study is a retrospective and prospective cohort, controlled, single-center, phase 1 study with a primary objective of evaluating the safety and radiographic outcomes associated with using IRRAS’ IRRAflow system compared to the current standard of care with external ventricular drains.  Dr. Christopher Kellner, Assistant Professor of Neurosurgery and Director of the Intracerebral Hemorrhage program at Mount Sinai, is the Principal Investigator of the study, which 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 versus 70 IRRAflow).

“We are excited to enroll our first patients in the DIVE study,” said Dr. Kellner. “We believe that the combination of irrigation and drainage has the potential to be a more efficient and cost-effective means to treat intraventricular hemorrhage than traditional passive drainage. Our first patient was successfully treated in just 67 hours, a significant reduction from our historic data for ICU and hospital length of stay.  This study will continue to enroll patients and assess outcomes.”

“Our growing partnership with Mount Sinai is another exciting step toward IRRAS becoming a leader in the treatment of intracranial bleeding,” said Will Martin, President and CEO of IRRAS.  “Working closely with such a prestigious institution and closely tracking the outcomes of their patients within the DIVE study will be an important piece of the growing pool of clinical evidence to support improved outcomes with IRRAflow for this critically ill group of patients.”

The Mount Sinai Health System is an internationally recognized leader in clinical neurosurgery, neurosurgery education, and neurosurgery research. For 2021-2022, Neurosurgery and Neurology at The Mount Sinai Hospital rank 9th in the United States, according to U.S. News and World Report.

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