Each year in the U.S., TBI results in over 200,000 hospitalizations and over 60,000 deaths.1 For severe cases with treatment-resistant intracranial pressure (ICP), only 10% result in good outcomes.2
ICP is commonly triggered by cerebral edema—brain swelling due to excess fluid. Identifying and treating cerebral edema is critical to managing severe TBI and other intracranial conditions.3
OsmoFlo Bimodal EVD Therapy: Targeting Elevated ICP
One practice for reducing ICP is draining cerebrospinal fluid (CSF) via a method called EVD—external ventricular drainage. Yet evidence is unclear whether EVD alone can reduce cerebral edema, possibly due to its impact on hydrostatic gradients instead of osmotic gradients.4
The OsmoFlo system adds a new approach designed to remove water from CSF as water vapor. This process aims to raise CSF osmolarity, causing water to move from cerebral tissue to CSF and, as a result, reducing edema and ICP.
A bimodal EVD system, it can be used to remove CSF water vapor or drain CSF.
The Latest on the OsmoFlo System
- Earned an FDA “breakthrough device” designation
- Funded with an $8M grant5 from the NIH Small Business Innovation Research (SBIR) program
- Planning near-term first-in-human clinical trials with Track-TBI, the premier U.S. TBI trial network
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References
1 Centers for Disease Control and Prevention. National Center for Health Statistics: Mortality Data on CDC WONDER.
2 Hutchinson PJ, Kolias AG, Timofeev IS, et al. Trial of Decompressive Craniectomy for Traumatic Intracranial Hypertension. N Engl J Med. 2016;375(12):1119-1130. doi:10.1056/NEJMoa1605215
3 Cook AM, Morgan Jones G, Hawryluk GWJ, Mailloux P, McLaughlin D, Papangelou A, Samuel S, Tokumaru S, Venkatasubramanian C, Zacko C, Zimmermann LL, Hirsch K, Shutter L. Guidelines for the Acute Treatment of Cerebral Edema in Neurocritical Care Patients. Neurocrit Care. 2020 Mar 29. doi: 10.1007/s12028-020-00959-7. Epub ahead of print. PMID: 32227294.
4 Simard, J.M., T.A. Kent, M. Chen, K.V. Tarasov, V. Gerzanich (2007). Brain oedema in focal ischemia: molecular pathophysiology and theoretical implications. Lancet Neurol 6:258-68
5 NIH #NS121557