📋 FDA Reference
Gore Tri-Lobe Balloon Catheter
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Summary: The GORE Tri-Lobe Balloon Catheter is a medical device used primarily in vascular procedures, particularly for venous stenting. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K033670 ↗
Decision Date ?
May 5, 2004
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The GORE Tri-Lobe Balloon Catheter was cleared via the FDA 510k pathway on May 5, 2004. Manufactured by W.L. Gore & Associates, it is classified as a Class 2 device under product code DQY.
What It Is
The GORE Tri-Lobe Balloon Catheter is a specialized catheter designed for use in endovascular procedures. It features a tri-lobe design that allows for precise control and positioning within blood vessels. This design is particularly beneficial in procedures requiring the temporary occlusion or dilation of veins, facilitating the placement of venous stents.
FDA-Cleared Indications
- For percutaneous use in endovascular procedures requiring temporary balloon occlusion or controlled dilation of a blood vessel.
- For use during procedures involving placement or treatment of venous stents, when balloon positioning and vessel-wall contact are needed.
- Use is limited to the specific catheter sizes, anatomical locations, and procedural applications described in the current FDA-cleared labeling and instructions for use.
Clinical Applications
- Balloon preparation, expansion, or modeling of venous stents during endovascular venous-stenting procedures.
- Temporary balloon occlusion or controlled dilation of a treated venous segment when appropriate for the labeled catheter size.
- Percutaneous endovascular treatment of venous obstruction when balloon control is required as part of a labeled intervention.
Reported off-label uses
- Temporary aortic balloon occlusion or resuscitative endovascular balloon occlusion of the aorta (REBOA) has been described for some balloon-catheter systems, but this use should not be assumed to be cleared for the GORE Tri-Lobe Balloon Catheter without confirming its current labeling.
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.
Practical Considerations
- Select the balloon diameter and catheter dimensions according to the target vessel, intended procedure, and current instructions for use; do not exceed the labeled inflation limits.
- The catheter is introduced percutaneously through vascular access and positioned with fluoroscopic or other appropriate imaging guidance.
- Confirm guidewire, sheath, compatibility, and access-site requirements before use. The operator should be trained in catheter-based vascular procedures and balloon inflation and deflation techniques.
- Review the current manufacturer labeling for contraindications, vessel-size restrictions, inflation media, and precautions. The available FDA record does not by itself establish MRI safety; MRI conditions must be confirmed from the current labeling.
- As a single-use catheter, it is discarded after the procedure and does not provide a permanent implant.
Related Literature
The linked study evaluated the use of the GORE Tri-Lobe Balloon Catheter as a partial REBOA (pREBOA) device in a porcine model of hemorrhagic shock. The study found that the catheter could effectively function as a pREBOA device, offering a minimally invasive alternative to traditional methods. However, the study was limited by its animal model and further research is needed to confirm these findings in human subjects.
Procedures that use this device
Frequently Asked Questions
What is the GORE Tri-Lobe Balloon Catheter used for?
It is used for endovascular procedures, particularly for venous stenting and temporary vessel occlusion.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving venous stenting and endovascular interventions.
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.