đź“Š Evidence-Based Reference
closurefast endovenous radiofrequency ablation catheter
Medtronic
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 510K
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.
Clinical Applications
This device is commonly used in the treatment of symptomatic varicose veins and chronic venous insufficiency. It is typically employed in minimally invasive procedures as an alternative to surgical vein stripping.
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.
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.