- Dr. Christopher Kellner from
Mount Sinai Health System successfully enrolled the first patients
in the DIVE (Deployment of Irrigating
Intraventricular Catheter System) study.
- DIVE is designed to measure the effectiveness of IRRAflow to
treat intraventricular hemorrhage versus standard EVD
treatment.
- The Neurosurgery and Neurology Departments at The Mount Sinai
Hospital were recently ranked 9th in the US, according
to U.S. News and World Report.
STOCKHOLM, Aug. 23, 2022 /PRNewswire/ -- 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.
About IRRAS
IRRAS is a global medical care company focused on delivering
innovative medical solutions to improve the lives of critically ill
patients. IRRAS designs, develops, and commercializes neurocritical
care products that transform patient outcomes and decrease the
overall cost of care by addressing complications associated with
current treatment methodologies. IRRAS markets and sells its
comprehensive, innovative IRRAflow and Hummingbird ICP
Monitoring product lines to hospitals worldwide through its direct
sales organization in the United
States and select European countries as well as an
international network of distribution partners.
IRRAS maintains its headquarters in Stockholm, Sweden, with corporate offices in
Munich, Germany, and San Diego, California, USA. For more
information, please visit www.irras.com.
IRRAS is listed on Nasdaq Stockholm (ticker: IRRAS).
For more information, please contact:
Sten Gustafsson
Director, Investor Relations
sten.gustafsson@irras.com
+46 102 11 5172
The information was released for public disclosure, through
the agency of the contact person above, on August 23, 2022, at 8:30 (CET).
This information was brought to you by Cision
http://news.cision.com
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