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The following articles/clinical evidence describes some uses of IRRAFlow that are not approved by the FDA, and the safety and effectiveness of any unapproved use(s) have not been established.
The FDA cleared indications of the IRRAflow Active Fluid Exchange System are as follows:
The use of IRRAflow Active Fluid Exchange System is indicated when intracranial pressure monitoring is required, and for externally draining intracranial fluid, as a means of reducing intracranial pressure in patients where an external drainage and monitoring system is needed.
For full information on contraindications and limitations, restrictions, cautions, warnings, or precautions in connection with the use of the IRRAflow Active Fluid Exchange System, please see the product Instructions for Use at https://irras.com/product/eifu/
The following contributors to these publications were paid consultants who received compensation from IRRAS at the time of writing, editing, or contributing to the publications:
Dr. Nicholas Brandmeir - West Virginia University School of Medicine
Dr. Behnam Rezai Jahromi - University of Helsinki
Dr. Sumeet Vadera - University of California Irvine
Dr. Alexandra Paul - Albany Medical Center
Dr. Adnan Siddiqui - University at Buffalo
Jeffrey Garavaglia - West Virginia University School of Medicine
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This clinical literature is provided for information and educational purposes only. The administration of specific fluids and medications using the IRRAflow Active Fluid Exchange System is not approved by the FDA, and reflects the authors’ clinical opinions and findings. The IRRAflow Active Fluid Exchange System is intended to deliver physician directed fluids, and is not indicated for administration of specific medications. Any medication selection, dosage, and method of administration is determined solely by the treating physician in accordance with their clinical judgment and regulatory requirements.
The FDA cleared indications of the IRRAflow Active Fluid Exchange System are as follows:
The use of IRRAflow Active Fluid Exchange System is indicated when intracranial pressure monitoring is required, and for externally draining intracranial fluid, as a means of reducing intracranial pressure in patients where an external drainage and monitoring system is needed.
The IRRAflow Active Fluid Exchange System is also intended to deliver physician directed fluids.
For full information on contraindications and limitations, restrictions, cautions, warnings, or precautions in connection with the use of the IRRAflow Active Fluid Exchange System, please see the product Instructions for Use at https://irras.com/product/eifu/
The following contributors to these publications were paid consultants who received compensation from IRRAS at the time of writing, editing, or contributing to the publications.
Dr. Nicholas Brandmeir - West Virginia University School of Medicine
Dr. Behnam Rezai Jahromi - University of Helsinki
Dr. Sumeet Vadera - University of California Irvine
Dr. Alexandra Paul - Albany Medical Center
Dr. Adnan Siddiqui - University at Buffalo
Jeffrey Garavaglia - West Virginia University School of Medicine
Click anywhere to continue
