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er-reboa catheter
Pryor Medical Devices
Summary: The ER-REBOA catheter is used for resuscitative endovascular balloon occlusion of the aorta in trauma patients. Key evidence highlights its effectiveness in achieving vascular access with varying success rates between techniques.
FDA Clearance Information
Pathway
510K
Number
K151821 ↗
Decision Date
October 23, 2015
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The ER-REBOA catheter was cleared by the FDA through the 510(k) pathway on October 23, 2015. It is manufactured by Pryor Medical Devices and classified as a Class 2 device.
What It Is
The ER-REBOA catheter is a medical device designed for resuscitative endovascular balloon occlusion of the aorta (REBOA). It is used to control hemorrhage in trauma patients by temporarily occluding blood flow in the aorta.
Clinical Applications
The ER-REBOA catheter is commonly used in emergency and trauma settings to manage severe hemorrhage. It is particularly useful in cases of exsanguinating trauma where rapid control of bleeding is critical.
Evidence Summary
The available literature includes 15 studies, comprising prospective observational case control studies and other study types, published between 2024 and earlier. These studies evaluate the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report varying success rates for vascular access using the ER-REBOA catheter. A study comparing percutaneous ultrasound-guided access to open cut-down access found success rates of 45% and 83%, respectively. The time required for vessel visualization and puncture was significantly shorter with ultrasound guidance.
Safety Profile
Reported complications include differences in time required for procedures, with ultrasound-guided access being faster for vessel visualization and puncture compared to open cut-down. No significant differences in balloon inflation times were noted.
Evidence Limitations
The evidence is limited by the small sample sizes and the variability in study designs. Further research is needed to explore long-term outcomes and to compare the ER-REBOA catheter with other resuscitative techniques.
Frequently Asked Questions
What are the clinical indications for ER-REBOA catheter?
The ER-REBOA catheter is indicated for use in resuscitative endovascular balloon occlusion of the aorta in trauma patients with severe hemorrhage.
What outcomes have been reported in clinical studies?
Clinical studies have reported success rates of 45% for ultrasound-guided access and 83% for open cut-down access, with faster procedure times for ultrasound guidance.
What complications have been reported?
Safety data indicate faster vessel visualization and puncture times with ultrasound guidance, but no significant differences in balloon inflation times were observed.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.