STOCKHOLM, July 22, 2020 /PRNewswire/ -- IRRAS AB, a
commercial stage medical technology company with a comprehensive
portfolio of innovative products for neurocritical care, today
announced the extension of the CE Mark until May 2024 for all components of its
IRRAflow system, including the IRRAflow control unit,
disposable Tube Set with digital pump, and both versions of the
IRRAflow dual-lumen drainage catheter.
"The extension of our CE Mark for IRRAflow is not only an
important milestone for our company, but it also reinforces the
need for innovative solutions for patients with intracranial
bleeding," said Kleanthis G.
Xanthopoulos, Ph.D., CEO of IRRAS. "Each year, 75% of
hemorrhagic strokes result in death or disability, and this
extension ensures that physicians will continue to have a next
generation, intelligent option for these critically ill
patients."
The CE Mark is issued by the European Commission and allows the
IRRAflow CNS system to be marketed throughout the EU member
nations for the external drainage of intracranial fluid and the
measurement of intracranial pressure (ICP) as a means of reducing
intracranial pressure. IRRAS received its initial CE Mark in 2014,
and the system's CE Mark recertification was completed in
December 2019. This extension of the
system's CE Mark certificate until May
2024 under existing Medical Device Directive (MDD) standards
ensures that the IRRAflow will remain commercially available
without interruption as the European Union transitions to the new
Medical Devices Regulation standards, which is scheduled to occur
in May 2021.
IRRAflow, the company's initial commercial product,
is a transformative medical device system that combines controlled
irrigation with ongoing fluid drainage to better manage patients
with intracranial bleedings. The system's automated use of
irrigation addresses challenges associated with traditional passive
fluid drainage, such as catheter blockages and infection. In
addition, IRRAflow's irrigating fluid helps to dilute toxic
material, such as blood or bacteria, that is collected within the
intracranial space and make it easier to remove.
"We're quite pleased to finalize the extension of the CE Mark
for IRRAflow until 2024. The regulatory environment in
Europe is evolving with the
transition to the new MDR standards, and this extension removes any
associated regulatory risk for IRRAflow for several years,"
said Will Martin, President and
Chief Commercial Officer of IRRAS. "Our commercial activities are
returning to normal after the covid-19 lockdowns, and this news
will permit us to continue our commercial acceleration throughout
the second half of 2020 and beyond."
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 AB (publ) is listed on Nasdaq Stockholm (ticker:
IRRAS).
For more information, please contact:
USA
Kleanthis G. Xanthopoulos,
Ph.D.
CEO
ir@irras.com
Europe
Sabina Berlin
CFO
+46 73 951 95 02
sabina.berlin@irras.com
The information was released for public disclosure, through
the agency of the contact person above, on July 22, 2020 at 09:45 (CET).
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/irras/r/irras-announces-extension-of-ce-mark-for-irraflow-system-until-may-2024,c3158257
View original
content:http://www.prnewswire.com/news-releases/irras-announces-extension-of-ce-mark-for-irraflow-system-until-may-2024-301097725.html
SOURCE IRRAS