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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 utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K081799 ↗
Decision Date
October 3, 2008
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The GORE Tri-Lobe Balloon Catheter was cleared via the FDA 510(k) pathway on October 3, 2008. Manufactured by W.L. Gore & Associates, it is classified as a Class 2 medical device.
What It Is
The GORE Tri-Lobe Balloon Catheter is a specialized catheter designed for use in vascular interventions. It features a tri-lobe design that allows for precise control and positioning within blood vessels. This device is particularly useful in procedures requiring balloon occlusion or dilation, providing clinicians with a reliable tool for managing vascular access and treatment.
Clinical Applications
This catheter is commonly used in procedures involving venous stenting and vascular occlusion. It is frequently employed in interventional radiology and vascular surgery settings, where precise control over blood flow is necessary. The device is suitable for use in patients requiring minimally invasive interventions to manage vascular conditions, including those with compromised blood flow or hemorrhagic shock.
Indications for Use
The FDA indications suggest that the GORE Tri-Lobe Balloon Catheter is intended for use in vascular procedures, particularly those involving the placement of venous stents. It is suitable for patients with conditions requiring controlled vascular access and occlusion.
Practical Considerations
Clinicians should be aware of the typical sizing options available for the GORE Tri-Lobe Balloon Catheter to ensure compatibility with specific patient anatomy. Proper technique is crucial for optimal performance, and familiarity with the device's tri-lobe design can enhance procedural outcomes.
Related Literature
The linked study evaluated the use of the GORE Tri-Lobe Balloon Catheter as a partial Resuscitative Endovascular Balloon Occlusion of the Aorta (pREBOA) device. Conducted in a porcine hemorrhagic shock model, the study compared the catheter's performance with existing REBOA and pREBOA techniques. Key findings highlighted the catheter's potential for effective aortic occlusion with reduced morbidity. However, the study's limitations include its animal model and the need for further clinical validation.
Frequently Asked Questions
What is the GORE Tri-Lobe Balloon Catheter used for?
It is used for vascular interventions, particularly in venous stenting and procedures requiring controlled vascular 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 vascular procedures, especially those involving venous stenting and controlled vascular access.
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.