IRRAS has announced the initial patient treatments with the company’s IRRAflow system within Mount Sinai Health System (New York, USA).
Thus far, two patients suffering from intraventricular haemorrhage (IVH) have been enrolled in the DIVE (Deployment of irrigating intraventricular catheter system) clinical trial, which will assess the IRRAflow system’s ability to treat patients experiencing IVH more effectively compared to traditional treatment with an external ventricular drain (EVD).
The DIVE study is a retrospective and prospective cohort, controlled, single-centre, 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 EVDs, according to a company press release.
Christopher Kellner (Mount Sinai, New York, USA) 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 and 70 IRRAflow).
“We are excited to enrol our first patients in the DIVE study,” said 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 haemorrhage than traditional passive drainage. Our first patient was successfully treated in just 67 hours, a significant reduction from our historic data for ICU [intensive care unit] and hospital length of stay. This study will continue to enrol patients and assess outcomes.”