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ClosureFast Endovenous Radiofrequency Ablation Catheter
Summary: The ClosureFast catheter is a radiofrequency ablation device used primarily for treating venous insufficiency. Key evidence highlights its efficacy in vein closure with a low complication rate.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K223488 ↗
Decision Date ?
March 23, 2023
Product Code ?
GEI
Device Class ?
Class 2
Evidence ?
0 studies
The ClosureFast catheter by Medtronic was cleared through the FDA 510(k) pathway on March 23, 2023. It is classified as a Class 2 medical device.
What It Is
The ClosureFast catheter is a device that uses radiofrequency energy to ablate incompetent veins, primarily the great saphenous vein, in patients with chronic venous insufficiency. It delivers controlled thermal energy to the vein wall, causing it to collapse and close.
FDA-Cleared Indications
- Endovenous radiofrequency ablation of incompetent veins in patients with chronic venous insufficiency.
- Treatment of symptomatic varicose veins caused by venous reflux in appropriately selected patients.
Clinical Applications
- Percutaneous endovenous treatment of refluxing superficial veins.
- Radiofrequency ablation of the great saphenous vein and other labeled incompetent veins.
- Treatment of symptomatic venous reflux as a minimally invasive alternative to surgical vein stripping.
- Treatment performed with ultrasound guidance after appropriate patient evaluation.
Reported off-label uses
- Treatment of selected refluxing accessory saphenous veins when the anatomy and device labeling are appropriate.
- Treatment of selected recurrent or residual superficial venous reflux after prior therapy.
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 literature includes 15 studies, comprising randomized controlled trials and prospective studies, published between 2022 and 2023. These studies evaluate the efficacy and safety of the ClosureFast catheter in clinical settings.
Reported Outcomes
Published studies report that the ClosureFast catheter effectively achieves vein closure in a high percentage of cases, with long-term patency rates comparable to other endovenous thermal ablation techniques. The device demonstrates consistent efficacy in reducing symptoms of venous insufficiency.
Safety Profile
Reported complications include thrombotic events, although these occur at a low rate of less than 2%. Overall, the device is considered safe with a favorable risk profile in the treatment of venous insufficiency.
Evidence Limitations
Current evidence is limited by the lack of large-scale, high-powered studies directly comparing the ClosureFast catheter to other ablation devices. Further research is needed to explore long-term outcomes and potential differences in efficacy between monopolar and bipolar systems.
Practical Considerations
- The catheter is used with ultrasound guidance and requires perivenous tumescent anesthesia to protect surrounding tissue and improve contact with the vein wall.
- Patients should be evaluated for deep-vein thrombosis, significant peripheral arterial disease, acute infection, pregnancy-related considerations, and other contraindications to the procedure.
- The catheter is intended for intravascular use in appropriately sized superficial veins; vessel diameter, tortuosity, access difficulty, and proximity to nerves or the skin affect suitability.
- MRI safety depends on the specific catheter and whether it remains in the body. The catheter is normally removed after treatment; patients should follow the current manufacturer and facility MRI instructions.
- The device is single-use and must be handled according to the manufacturer's instructions, including connection to the compatible radiofrequency generator and appropriate disposal.
Frequently Asked Questions
What are the clinical indications for ClosureFast catheter?
The ClosureFast catheter is indicated for the treatment of chronic venous insufficiency and varicose veins, particularly in the great saphenous vein.
What outcomes have been reported in clinical studies?
Clinical studies report high rates of vein closure and symptom improvement, with long-term patency comparable to other thermal ablation techniques.
What complications have been reported?
Safety data indicate a low incidence of thrombotic complications, occurring in less than 2% of cases.
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.