- IRRAS received US FDA 510(k) clearance for its class II
next-generation IRRAflow control unit that enhances the procedural
workflow for health care professionals treating critically ill
patients suffering from intracranial bleeds.
- The cleared enhancements made to the next-generation
IRRAflow control unit include additional functionality to the
system's user interface software that permits communication and
data transmission to the hospital's bedside monitor.
STOCKHOLM, Dec. 12, 2022 /PRNewswire/ -- IRRAS, a
commercial-stage medical technology company with a comprehensive
portfolio of innovative products for neurocritical care, today
announced that it received regulatory clearance from the United
States Food, Drug, and Administration (FDA) to active all of the
functionality on the next generation control unit for its flagship
product, IRRAflow, the world's first and only active fluid
exchange system.
Earlier this year, IRRAS introduced this next-generation
IRRAflow system, which included embedded interactive
tutorials, intuitive software with upgraded graphics, refined
treatment workflow, and a new drainage collection design, to its
customers in the US. This most recent FDA 510(k) clearance
extends the system's previous FDA clearances and permits the
activation of software functionality that connects to the patient's
bedside monitor and openly transmits treatment information to the
central nursing station.
The IRRAflow system advances treatment options for
patients suffering from intracranial bleeding as the first
irrigating drainage system that enables active fluid exchange.
IRRAflow combines automated irrigation, controlled drainage,
and continuous monitoring of the patient's intracranial pressure
(ICP) into one intelligent system. Its unique mechanism of
action uses recurring irrigation to prevent solid particles from
blocking the drainage holes on the catheter tip and to also dilute
collected toxic material, making it easier to remove.
"IRRAS prides itself on consistently upgrading its products to
better meet the needs of its customers, and the US regulatory
clearance of the next generation IRRAflow control unit is
the latest example of our team delivering upon that promise," said
Will Martin, President and Chief
Executive Officer of IRRAS. "Our team remains focused upon
incorporating customer feedback into our technologies to enhance
the user experience and optimize care for their critically ill
patients. Being able to introduce the latest IRRAflow
functionality is the exciting next step toward accomplishing our
mission to becoming a global leader in the neurocritical
space."
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 December 12, 2022, at 8:00 (CET).
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