STOCKHOLM, Sweden, Dec. 19, 2019 /PRNewswire/ -- IRRAS, a
global healthcare company with a comprehensive portfolio of
innovative products for neurocritical care, announced today
that it received CE Mark approval for its
IRRAflow® catheter. This CE Mark complements
the two CE Marks previously obtained for the IRRAflow
system's tube set with digital pump and control unit, and allows
IRRAS to once again commercially market the IRRAflow system
in the European Union. The complete IRRAflow CNS System
received approval for CE Mark today and will be ready for
commercial launch in the EU.
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. In April
2018, IRRAS received an updated ISO 13485:2016 certificate
and updated CE Mark approvals for both the control unit and tube
set with digital pump in the IRRAflow system, both of which
are Class II products. The proprietary IRRAflow catheter,
however, is a Class III product, and required more time to
review.
"We are pleased to receive the final CE Mark for IRRAflow
in Europe, which is a
strategically important geography for IRRAS," said Kleanthis G. Xanthopoulos, Ph.D., President and
CEO of IRRAS. "With this approval, we can now ramp up our marketing
and sales efforts for the initiation of product sales in the key EU
market."
"In my previous patient treatment experience with
IRRAflow, I found the system's combination of irrigation and
drainage to be a valuable tool in treating my critically ill
patients with intracranial bleeding and brain infections," said Dr.
Behnam Rezai Jahromi, Neurosurgeon
from Helsinki University Hospital in
Helsinki, Finland. "Innovation in
neurocritical care has been limited through the years, and I look
forward to studying the potential impact of IRRAflow more
closely in the future."
"Over the past year, we have seen many successful case outcomes
and significant customer interest across a variety of neurosurgery
procedures with IRRAflow, therefore, we are thrilled to be
able to continue our expansion to Europe," said Will
Martin, IRRAS' Chief Commercial Officer. Based on this early
experience, we are confident that IRRAflow will continue to
significantly improve patient outcomes and result in sustained
sales growth."
About IRRAS
IRRAS AB is a global healthcare company focused on delivering
innovative medical technologies to our customers and their
patients. IRRAS designs, develops and commercializes products that
improve patient outcomes and decrease the overall cost of care by
addressing complications associated with current treatment methods
in neurocritical care. IRRAS markets and sells its products to
hospitals worldwide through its direct sales organizations in the
U.S. and select European countries and a network of distribution
partners in other markets.
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 First North Premier Growth
Market (ticker: IRRAS). Redeye AB is certified adviser of the
company with email certifiedadviser@redeye.se or phone +46 8 121
576 90.
For more information, please contact:
USA
Kleanthis G. Xanthopoulos, Ph.D.
President and CEO
ir@irras.com
Europa
Sabina Berlin
CFO
+46 73 951 95 02
sabina.berlin@irras.com
This document is considered information that IRRAS is obliged
to disclose pursuant to the EU Market Abuse Regulation. The
information was released for public disclosure, through the agency
of the contact person above, on December 19,
2019 at 8.30 p.m.
(CET).
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/irras/r/irras-receives-renewed-ce-mark-for-the-irraflow-catheter,c2995953
The following files are available for download:
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SOURCE IRRAS