to evaluate the efficacy and safety of the IRRAflow system’s active irrigation and drainage compared to passive external ventricular drainage (EVD) alone.
The ACTIVE study is a randomized, prospective clinical trial that consists of two arms. The first arm will assess the treatment of 60 IVH patients using IRRAflow and will compare the results to a second arm of 58 patients that will be treated with traditional passive EVDs. The study will compare overall effectiveness of the two treatment arms by looking at overall blood clearance, treatment time required, and long-term patient outcomes. Additionally, the safety of each treatment arm will be compared by assessing treatment complications, including catheter occlusions and infection. The clinical trial has also been designed for endpoint comparisons to be conducted at multiple interim checkpoints throughout enrollment.
“We are pleased to enroll our first patient in the ACTIVE study,” said Dr. Anders Korshøj. “We believe that the use of active irrigation may enhance outcomes for IVH patients, and we look forward to presenting our data from ACTIVE to confirm that IRRAflow’s unique mechanism of action reduces complications and treatment times.”
The Department of Neurosurgery at Aarhus University Hospital is one of the leading neurosurgical departments in Denmark. The department is responsible for general neurosurgery and highly specialized neurosurgical procedures in the central Denmark Region. Moreover, the department is responsible for diagnostics, treatment, and care of patients with certain neurosurgical conditions in the entire country.
“The first patient enrollment of the ACTIVE study is a critical step forward for our company,” said Will Martin, President and CEO of IRRAS. “The most important step to accelerate the commercial adoption of IRRAflow is to confirm its superiority to traditional drainage, and the ACTIVE trial will provide comparative data that demonstrates how IRRAflow is a better choice for patients suffering from IVH.”
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 is listed on Nasdaq Stockholm (ticker: IRRAS).
About Aarhus University and Aarhus University Hospital
Aarhus University Hospital belongs to the elite of university hospitals. Aarhus University Hospital develops and provides highly specialized medical treatment, research, and education at an international level. Aarhus University Hospital serves the citizens from across the Central Denmark Region in need of highly specialized treatment. For the last 13 years, Aarhus University Hospital has been appointed Denmark’s best hospital, and it currently ranks #32 on the Newsweek ranking of the world’s best hospitals.
Aarhus University (AU) is a dynamic, modern and highly international university. Since its founding in 1928, it has grown to become a leading public university with international impact and reach across the entire research spectrum. Out of over 17,000 universities worldwide, AU ranks among the top 100 universities in the world in several research areas and is considered among the top 25 universities in the European Union. AU stands out in particular in terms of research quality and the quality of degree programs. Regarding internationalization, AU is ranked in the top as well as no. 45 on THE’s ranking “Most International Universities in the World”.
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The information was released for public disclosure, through the agency of the contact person above, on January 28, 2022, at 8:30 (CET).