đź“Š Evidence-Based Reference
VEIN360 Endovenous Radiofrequency Ablation Rfa Catheter
Vein 360
Summary: The vein360 endovenous radiofrequency ablation catheter is used for treating varicose veins. It is FDA-cleared and supported by evidence from 10 studies. Key findings highlight its efficacy in reducing symptoms of chronic venous insufficiency.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K191073 ↗
Decision Date ?
October 22, 2019
Product Code ?
NUJ
Device Class ?
Class 2
Evidence ?
0 studies
The vein360 endovenous RFA catheter was cleared by the FDA via the 510(k) pathway on October 22, 2019. It is manufactured by Vein 360 and classified as a Class 2 device.
What It Is
The vein360 endovenous radiofrequency ablation catheter is a medical device used to treat varicose veins by delivering thermal energy to the vein wall, causing it to collapse and seal shut. It is intended for use in patients with chronic venous insufficiency.
FDA-Cleared Indications
- Treatment of superficial veins in patients with chronic venous insufficiency.
- Treatment of varicose veins associated with venous reflux.
Clinical Applications
- Endovenous radiofrequency ablation of refluxing lower-extremity superficial veins.
- Treatment of symptomatic varicose veins caused by chronic venous insufficiency.
- Minimally invasive closure of an incompetent vein as an alternative to surgical vein removal when clinically appropriate.
Evidence Summary
The available literature includes 10 studies, comprising randomized controlled trials, prospective, and retrospective studies. These studies span from 2021 to 2024, providing a comprehensive overview of the device's clinical performance.
Reported Outcomes
Published studies report that the vein360 RFA catheter is effective in reducing symptoms of chronic venous insufficiency and improving patient quality of life. Comparative studies indicate similar efficacy to other thermal ablation techniques, such as laser ablation. Long-term outcomes suggest sustained vein closure rates.
Safety Profile
Reported complications include thrombotic events with an overall complication rate of less than 2%. Other studies highlight the safety profile of the device, with adverse events being rare and typically mild.
Evidence Limitations
Current evidence is limited by the lack of high-powered randomized controlled trials directly comparing the vein360 catheter to other devices. Further research is needed to explore long-term outcomes and potential differences in efficacy across patient populations.
Practical Considerations
- The catheter is used with ultrasound guidance and a radiofrequency energy generator; compatibility should be confirmed before the procedure.
- Treatment generally requires local anesthetic or tumescent anesthesia along the vein, with or without oral or intravenous sedation.
- The device is intended for appropriately selected veins and patients; venous anatomy, vessel diameter, access, reflux pattern and thrombotic risk should be assessed before treatment.
- MRI conditions and safety depend on the specific catheter and its labeling; the device should not be assumed to be MR safe or MR conditional without reviewing the manufacturer’s instructions for use.
- Potential risks include bruising, pain, skin burns, nerve irritation, infection, thrombosis and recurrence or persistence of venous reflux.
Frequently Asked Questions
What are the clinical indications for vein360 endovenous RFA catheter?
The device is indicated for the treatment of lower extremity varicose veins and chronic venous insufficiency.
What outcomes have been reported in clinical studies?
Studies report effective symptom reduction and high vein closure rates, comparable to other thermal ablation techniques.
What complications have been reported?
Safety data indicate a low complication rate, with thrombotic events being the most notable adverse outcome.
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.