The STRIDE clinical trial is evaluating the safety and efficacy of the investigational eShunt System—an endovascular approach to normal pressure hydocephalus (NPH) treatment
Caution: The eShunt System is an ivestigational device. Limited by United States law to investigational use only. The safety and effectiveness of the eShunt System have not been established.
The STRIDE clinical trial is evaluating the safety and efficacy of the investigational eShunt System—an endovascular approach to normal pressure hydocephalus (NPH) treatment
Caution: The eShunt System is an investigational device. Limited by United States law to investigational use only. The safety and effectiveness of the eShunt System have not been established.
The STRIDE clinical trial is the largest, randomized, controlled trial in the treatment of NPH comparing the new, investigational endovascular eShunt® System vs the standard of care VP shunt.
Total of 200 treated participants
eShunt® System Group: 100 patients to receive endovascular treatment with the eShunt® System
VP Shunt Group: 100 patients to receive traditional VP shunt procedure/device
1 year of follow-up post procedure with up to 5 years of focused care
Improvement in gait impairment at 6 months compared to baseline.
Improvement defined as a reduction in time to complete the TUG test, which requires patients to stand up, walk 10 feet, turn around, walk 10 feet, and sit back down
Comparison of the total number of adverse events observed within the first 6 months following treatment.
TUG, Timed Up and Go; VP, ventriculoperitoneal
Your patients with NPH may be right and ready for the STRIDE clinical trial.
*CT, computed tomography; MoCA, Montreal Cognitive Assessment; MRI, magnetic resonance imaging.
Treatment with the eShunt System does not preclude future use of VP shunt, if needed
The endovascular eShunt System is an investigational CSF shunt for people with NPH that does not require brain surgery.
The eShunt System is the only endovascular shunt and the first new treatment option developed for NPH since VP shunts were introduced more than 60 years ago.
Traditional VP Shunts |
The Endovascular eShunt System |
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Studies have shown VP shunts to be effective, despite the high complication rates reported during and after surgery¹ |
A new, investigational device with the potential to reduce patient and caregiver burden due to challenges seen with VP shunts* *Refer to the eShunt® System Instructions for Use for list of potential risks. |
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Requires invasive, open brain surgery² |
Uses a minimally invasive, endovascular approach with femoral venous access |
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Drains excess CSF by routing it to another location in the body to be absorbed² |
Designed to drain excess CSF in the brain by mimicking the body's natural drainage process |
Studies have shown VP shunts to be effective, despite the high complication rates reported during and after surgery¹
Requires invasive, open brain surgery²
Drains excess CSF by routing it to another location in the body to be absorbed²
A new, investigational device with the potential to reduce patient and caregiver burden due to challenges seen with VP shunts*
*Refer to the eShunt® System Instructions for Use for list of potential risks.
Uses a minimally invasive, endovascular approach with femoral venous access
Designed to drain excess CSF in the brain by mimicking the body's natural drainage process
The FDA recently designated the eShunt System as a Breakthrough Device because of
its potential to provide improved treatment for NPH³†
FDA, Food and Drug Administration.
†Breakthrough designation does not imply approval or guaranteed safety and effectiveness.
The FDA recently designated the eShunt System as a Breakthrough Device because of its potential to provide improved treatment for NPH³†
FDA, Food and Drug Administration.
†Breakthrough designation does not imply approval or guaranteed safety and effectiveness.
REFERENCES: 1. Nadel JL, Wilkinson DA, Linzey JR, Maher CO, Kotagal V, Heth JA. Neurosurgery. 2020;84(6):843–850. 2. Hydrocephalus Associate website. Shunt systems. Accessed October 16, 2024. https://www.hydroassoc.org/shunt-systems/ 3. National Institute of Health website. Breakthrough device designation requests. Accessed October 7, 2024. https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program
REFERENCES: 1. Nadel JL, Wilkinson DA, Linzey JR, Maher CO, Kotagal V, Heth JA. Neurosurgery. 2020;84(6):843–850. 2. Hydrocephalus Associate website. Shunt systems. Accessed October 16, 2024. https://www.hydroassoc.org/shunt-systems/ 3. National Institute of Health website. Breakthrough device designation requests. Accessed October 7, 2024. https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program
