- Neurosurgeons from the Jacobs School of Medicine and
Biomedical Sciences, University at
Buffalo, Buffalo, New York,
published data in the March issue of Operative Neurosurgery that
compared procedural and clinical outcomes when treating chronic
subdural hematomas with IRRAflow against passive drainage
alone.
- The study demonstrated that IRRAflow's active and automated
continuous irrigation plus drainage resulted in faster hematoma
clearance and a reduction in catheter-related infection, thus
leading to favorable clinical outcomes and low complication and
revision rates when compared with passive drainage.
STOCKHOLM, Feb. 13, 2023 /PRNewswire/ -- IRRAS, a
commercial-stage medical technology company with a comprehensive
portfolio of innovative products for neurocritical care, today
announced that the publication of the first comparative study
detailing the use of the company's novel IRRAflow
system. This study, which was conducted under the guidance of
Dr. Adnan Siddiqui and the team from
the Department of Neurosurgery, Jacobs School of Medicine and
Biomedical Sciences, University at
Buffalo, one of the world's leading centers for
neurosurgical innovation, was published in the peer-reviewed
Operative Neurosurgery medical journal. The manuscript
concludes that IRRAS' IRRAflow system when used for the
treatment of chronic subdural hematomas (cSDH) results in favorable
clinical outcomes, low complication and revision rates, faster
clearance of collected blood, and reduced rates of catheter
infections compared to passive drainage using an external
ventricular drain (EVD).
The manuscript, titled "Use of Novel Automated Active Irrigation
With Drainage Versus Passive Drainage Alone for Chronic Subdural
Hematoma—A Propensity Score-Matched Comparative Study With
Volumetric Analysis," retrospectively analyzed the treatment of 55
patients, 21 treated with IRRAflow and 34 treated with
passive drainage, that underwent propensity score matching to
ensure appropriate similarities in patient demographics, baseline
comorbidities, and hematoma volume.
After the completion of the analysis, the surgeons found that
the use of IRRAflow resulted in a statistically significant
higher rate of hematoma clearance (0.5 ± 0.4 mL/day with
IRRAflow vs. 0.4 ± 0.5 mL/day with passive drainage) and a
statistically significant reduction in catheter-related
infections. Additionally, in the subgroup analysis that
looked procedures that were performed using a burrhole alone,
treatment with IRRAflow also resulted in significantly lower
hematoma expansion at discharge and significantly improved brain
expansion.
Furthermore, the data from this clinical study showed that the
use of IRRAflow resulted in a nonsignificant reduction in
duration of catheter placement (3.7 ± 2.2 with IRRAflow vs.
4.4 ± 4.1 with passive drainage), total hospital length of stay
(6.8 ± 3.0 with IRRAflow vs. 10.6 ± 16.2 with passive
drainage), and rate of seizure activity (0 patients with
IRRAflow vs. 3 patients with passive drainage), each
suggesting a trend that may have shown significance with a larger
sample size.
A chronic subdural hematoma is a collection of blood and blood
breakdown products between the surface of the brain and its outer
layer that generally occurs after head trauma in an older
patient. As the world's population progressively ages, the
increasing incidence of cSDH will be a burden to patients and
a future challenge for neurosurgical
clinics.[1] The incidence of chronic subdural
hematomas (CSDH) ranges from 1.72 to 20.6 per 100,000 persons
per year and is projected to become the most common cranial
neurosurgical condition among adults by the year
2030.[2],[3]
"This recently published clinical data confirms the positive
impact that IRRAflow can have on the lives of patients
suffering from intracranial bleeding," said Will Martin, President and Chief Executive
Officer of IRRAS. "This study is a critical next step in the
growing pool of clinical evidence that demonstrates the impact of
IRRAflow by providing head-to-head data that confirms that
IRRAflow's combination of irrigation and drainage results in
both more effective blood removal and safer clinical outcomes than
traditional treatment methods."
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 February 13, 2023, at 8:30 (CET).
[1] Rauhala M, Luoto TM, Huhtala H, Iverson GL,
Niskakangas T, Öhman J, Helén P. The incidence of chronic subdural
hematomas from 1990 to 2015 in a defined Finnish population. J
Neurosurg. 2019 Mar 22:1-11. doi: 10.3171/2018.12.JNS183035. [Epub
ahead of print] PubMed PMID: 30901751.
[2] Yang W, Huang J. Chronic Subdural Hematoma:
Epidemiology and Natural History. Neurosurg Clin N Am. 2017
Apr;28(2):205-210. doi: 10.1016/j.nec.2016.11.002. Epub 2017
Feb 1. Review. PubMed PMID:
28325454
[3] Balser D, Farooq S, Mehmood T, Reyes M,
Samadani U. Actual and projected incidence rates for chronic
subdural hematomas in United
States Veterans Administration and civilian populations. J
Neurosurg. 2015 Mar 20:1-7. [Epub ahead of print] PubMed PMID:
25794342; PubMed Central PMCID: PMC4575892.
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content:https://www.prnewswire.co.uk/news-releases/irraflow-system-confirmed-to-more-effectively-remove-collected-blood-and-reduce-catheter-infection-rates-than-passive-drainage-in-head-to-head-analysis-301744909.html