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gore tri-lobe balloon catheter
W.L. Gore & Associates
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
510K
Number
K033670 ↗
Decision Date
May 5, 2004
Product Code
DQY
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.
Clinical Applications
This catheter is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in procedures involving venous stenting, where precise control and positioning are critical. The device is suitable for use in patients requiring endovascular interventions, such as those with venous obstructions or requiring resuscitative procedures like REBOA.
Indications for Use
The FDA indications suggest that the GORE Tri-Lobe Balloon Catheter is intended for use in procedures involving venous stenting. It is suitable for patients who require endovascular interventions to manage venous obstructions or other related conditions.
Practical Considerations
The GORE Tri-Lobe Balloon Catheter is available in various sizes to accommodate different vessel diameters. It is compatible with standard endovascular equipment and requires careful handling to ensure precise placement. Clinicians should be familiar with catheterization techniques to optimize its use.
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.
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.