đź“Š Evidence-Based Reference
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 ?
510(k)
Number ?
K151821 ↗
Decision Date ?
October 23, 2015
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Temporary occlusion of the aorta during resuscitative endovascular balloon occlusion of the aorta (REBOA).
- Use in patients requiring control of blood flow in the aorta during emergency management of severe hemorrhage.
Clinical Applications
- Temporary aortic occlusion during resuscitation of selected trauma patients with life-threatening hemorrhage.
- Hemorrhage control for severe bleeding below the diaphragm when proximal aortic control is needed.
- Percutaneous placement through an arterial access site under imaging guidance in an emergency or trauma setting.
Reported off-label uses
- Temporary aortic occlusion in selected nontraumatic hemorrhage cases has been described in clinical practice, but this may be outside the device labeling and requires specialist judgment.
- Use in other causes of noncompressible torso hemorrhage has been reported for REBOA-type catheters, but should not be assumed to be FDA-cleared for every indication.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The catheter is introduced through arterial access, commonly through the common femoral artery, and positioned in the appropriate aortic zone using fluoroscopy, ultrasound, or other validated imaging methods.
- The balloon is intended for temporary occlusion; prolonged inflation can cause limb ischemia, visceral ischemia, spinal cord ischemia, or other ischemic complications.
- Operators must confirm catheter, guidewire, sheath, and vessel-size compatibility before use and follow the current manufacturer instructions for balloon inflation and maximum recommended volumes.
- The device is used in an emergency setting and requires trained personnel, continuous hemodynamic monitoring, and a plan for definitive hemorrhage control, such as surgery or embolization.
- MRI safety and conditional-use information should be confirmed in the current manufacturer labeling; do not place the catheter in an MRI environment unless its status and conditions are known.
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.