Superficial vein
ClosureFast™ radiofrequency ablation (RFA) system
<p>The ClosureFast™ procedure uses radiofrequency energy to treat patients with superficial vein disease.</p>
Explore the ClosureFast™ RFA system.
Technology you know and trust
Gap-free thermal ablation
The ClosureFast™ RFA system delivers uniform heat for lasting vein closure.1
- Patented segmental procedure
- Less pain and bruising than laser energy treatment2
- Proven clinical results and rapid patient recovery1,2
Data are from ClosureFast™ 7 Fr studies. ClosureFast™ 6 Fr catheter is designed to provide the same outcomes as established by ClosureFast™ 7 Fr catheter.
Catheter inserted
into vein
Controlled heat
collapses vein
Catheter withdrawn,
closing vein
Proven procedure, lower profile
The ClosureFast™ radiofrequency ablation catheter is now available in 6F, designed for†,‡:
- Enhanced flexibility
- Improved navigation
- Increased kink resistance
† Compared to ClosureFast™ 7 Fr catheter and Venclose™* catheter in bench testing.
‡ Bench test data on file at Medtronic. N = 15 Venclose™* catheters and 30 each ClosureFast™ 6 Fr and 7 Fr catheters. Bench tests may not be indicative of clinical performance.
Deliver lasting results with gap-free thermal ablation.
The ClosureFast™ procedure features a patented overlap of 0.5 cm at each thermal treatment segment, eliminating gaps between segments ― for lasting vein closure.1,3
6F profile, 8 cm heating length
1. 8 cm ablation
2. 0.5 cm overlap
3. 8 cm ablation
Note: 3 cm (7F) heating length available for shorter segments.
Clinical evidence
- 72% improvement in VCSS scores at 5 years4
- 91.9% closure at 5 years1
- 94.9% reflux-free rate at 5 years1
- 3M+ patients treated5
- 200+ published articles and clinical studies6
- 2006: U.S. FDA clearance 7F catheter
Data are from ClosureFast™ 7F studies. ClosureFast™ 6F catheter is designed to provide the same outcomes as established by ClosureFast™ 7F catheter.
Indications
The ClosureFast™ radiofrequency ablation catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
System components
ClosureFast™ radiofrequency ablation catheter
- The ClosureFast™ radiofrequency ablation catheter precisely heats an 8 cm vein segment (or 3 cm for shorter, refluxing vein lengths) in one 20-second interval.
- The heat provided by the catheter shrinks and collapses the target vein, creating a fibrotic seal and occluding the vessel.
ClosureFast™ radiofrequency stylet
- The ClosureRFS™ radiofrequency stylet is an intravascular ablation device specifically intended for the treatment of incompetent perforator and tributary veins.
- This minimally invasive outpatient procedure leaves minimal scarring at the puncture site and can be either the primary treatment or an adjunct treatment using the ClosureFast™ radiofrequency ablation catheter.
ClosureFast™ radiofrequency generator
- The ClosureRFG™ generator delivers radiofrequency energy to the ClosureFast™ radiofrequency ablation catheter and the ClosureRFS™ radiofrequency stylet for the effective treatment of CVI.
- The controlled feedback mechanism monitors intravascular heat parameters in real time to automatically regulate therapeutic power.
Adverse events may include hematoma, phlebitis, skin injury, nerve injury, thrombophlebitis, thrombosis, and/or pulmonary embolism.
Frequently asked questions
The ClosureFast™ RFA system is a medical device used to treat superficial venous reflux. It consists of the ClosureFast™ catheter and ClosureRFG™ radiofrequency generator. The catheter delivers thermal energy via radiofrequency heating to shrink and collapse the target vein, creating a fibrotic seal and occluding the vessel.
The ClosureFast™ procedure demonstrates a 91.9% closure rate at five years, with long-term clinical data supporting its safety and efficacy.1 It provides lasting vein closure through uniform heat delivery, with a 94.9% reflux-free rate at five years.1
The ClosureFast™ system is designed for use with the ClosureRFG™ generator, model RFG3. ClosureFast™ catheters are available in 6F and 7F with 3 heating lengths, 8 cm for the 6F catheter and 3 cm or 7 cm for the 7F catheter. The ClosureRFS™ stylet, is also available for the treatment of incompetent perforator and tributary veins. See the ordering information table for more details.
The ClosureFast™ RFA system is considered safe, with over 3 million patients treated worldwide and a 91.9% closure rate at five years.1,5 Potential complications include, but are not limited to, the following: adjacent nerve injury, hematoma, pulmonary embolism, thrombosis, infection, phlebitis, skin burn or discoloration, and vessel perforation.
The ClosureFast™ procedure is contraindicated for patients with thrombus in the target vein segment. Potential complications include, but are not limited to, the following: adjacent nerve injury, hematoma, pulmonary embolism, thrombosis, infection, phlebitis, skin burn or discoloration, and vessel perforation.
ClosureFast™ radiofrequency ablation (RFA) and endovenous laser ablation (EVLA) differ in several aspects. The ClosureFast™ procedure delivers thermal energy in consistent 20-second segmental intervals, reducing variability and ensuring reliable occlusions. EVLA may experience inconsistencies due to variable pullback speeds, potentially leading to higher complication or recurrence rates. The ClosureFast™ procedure is associated with fewer complications, less postoperative pain, and lower clinical recurrence rates at five years compared to EVLA. Additionally, the ClosureFast™ procedure requires less specialist safety equipment and offers a more comfortable procedure with less bruising.1,2
Ordering information
ClosureFast™ system catheter
| Item number | CF6-8-60 | CF6-8-100 | CF7-3-60 | CF7-7-60 | CF7-7-100 |
|---|---|---|---|---|---|
| Introducer sheath (min. ID size) | 6 Fr (2.0 mm) | 6 Fr (2.0 mm) | 7 Fr (2.3 mm) | 7 Fr (2.3 mm) | 7 Fr (2.3 mm) |
| Insertable length (cm) | 60 | 100 | 60 | 60 | 100 |
| Heating element diameter (mm) | 2.0 | 2.0 | 2.3 | 2.3 | 2.3 |
| Heating element length (cm) | 8 | 8 | 3 | 7 | 7 |
| Maximum power setting (W) | 40 | 40 | 18 | 40 | 40 |
| Default target temperature setting (C) | 120 | 120 | 120 | 120 | 120 |
| Software version: RFG2 | 4.0.0 or higher | 4.0.0 or higher | 4.4.0 or higher | 4.0.0 or higher | 4.0.0 or higher |
| Software version: RFG3 | 1.11.0 or higher | 1.11.0 or higher | 1.11.0 or higher | 1.11.0 or higher | 1.11.0 or higher |
| Compatible guidewire (in) | 0.025 | 0.025 | 0.025 | 0.025 | 0.025 |
ClosureRFG™ generator
| Item number | Voltage | Height (cm / in) | Width (cm / in) | Depth (cm / in) | Weight (kg / lbs.) |
|---|---|---|---|---|---|
| RFG3 | Universal — 100-240 V | 26.7 / 10.5 | 34 / 13.4 | 17.3 / 6.8 | 6.8 / 15 maximum |
ClosureFast™ system accessories
| Item number | Description |
|---|---|
| CFP | Procedure pack — scalpel, surgical marking pen, probe cover, table cover, plastic clamp towel, custom label, sharps block, skin closure strip, gowns, dry sponge sticks, bowls, drapes, table cover tapes, needles, and more |
| MIS-7F07 | Micro introducer sheath set — 7 Fr x 7 cm, 21 ga TW needle, guidewire: 0.018 in x 45 cm, single-ended: straight |
| MIS-7F11 | Micro introducer sheath set — 7 Fr x 11 cm, 21 ga TW needle, guidewire: 0.018 in x 45 cm, single-ended: straight |
| MIS-6F07 | Micro introducer sheath set — 6 Fr x 7 cm, 21 ga TW needle, guidewire: 0.018 in, 45 cm, single-ended: straight |
| MIS-6F11 | Micro introducer sheath set — 6 Fr x 11 cm, 21 ga x TW needle, guidewire: 0.018 in, 45 cm, single-ended: straight |
| IS-7F07 | Introducer sheath set — 7 Fr x 7 cm, 19 ga UTW needle, guidewire: 0.035 in x 45 cm, J / straight double-ended |
| IS-7F11 | Introducer sheath set — 7 Fr x 11 cm, 19 ga UTW needle, guidewire: 0.035 in x 45 cm, J / straight double-ended |
| MPK-4F | Micro puncture kit — 4 Fr, 21 ga TW needle, guidewire: 0.018 in x 45 cm, single-ended: straight |
| MPK-5F | Micro puncture kit — 5 Fr, 21 ga TW needle, guidewire: 0.018 in x 45 cm, single-ended: straight |
| AN-19G | Percutaneous entry needle — 19 ga, length: 2.75 in, UTW |
| AN-19GE | Percutaneous entry needle — 19 ga, length: 2.75 in, UTW echogenic tip |
| AN-21G | Percutaneous entry needle — 21 ga, length: 2.75 in, TW |
| AN-21GE | Percutaneous entry needle — 21 ga, length: 2.75 in, TW echogenic tip |
| GW-018-45-SS | Guidewire — diameter: 0.018 in, length: 45 cm, single-ended: straight, fixed core, PTFE coated |
| GW-025-150-DE1.5J | Guidewire — diameter: 0.025 in, length: 150 cm, double-ended: 1.5 mm J and straight, fixed core, PTFE coated |
| GW-025-260-1.5J | Guidewire — diameter: 0.025 in, length: 260 cm, single-ended: 1.5 mm J, fixed core, PTFE coated |
| GW-035-45 | Guidewire — diameter: 0.035 in, length: 45 cm, double-ended: 3 mm J and straight, fixed core, PTFE coated |
| PC-6X96 | Ultrasound probe cover |
| KIP-II | Tumescent infiltration pump |
| TIK-01 | Tumescent infiltration kit — 12 mL syringe, 108 in tube length |
| TTUB-4 | Tumescent infiltration pump tubing set — tube length: 4 M |
TM* Third-party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.
- Proebstle TM, Alm BJ, Göckeritz O, et al. Five-year results from the prospective European multicentre cohort study on radiofrequency segmental thermal ablation for incompetent great saphenous veins. Br J Surg. 2015;102(3):212–218. doi:10.1002/bjs.9679.
- Almeida JI, Kaufman J, Göckeritz O, et al. Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: A multicenter, single-blinded, randomized study (RECOVERY Study). J Vasc Interv Radiol. 2009;20(6):752–759. doi:10.1016/j.jvir.2009.03.008.
- ClosureFast™ and ClosureFast™ RFS patents. Medtronic data on file, 2022.
- Morrison N, Gibson K, Vasquez M, Weiss R, Jones A. Five-year extension study of patients from a randomized clinical trial (VeClose) comparing cyanoacrylate closure versus radiofrequency ablation for the treatment of incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2020;8(6):978–989. doi:10.1016/j.jvsv.2019.12.080.
- ClosureFast™ procedures. Medtronic data on file, 2024.
- Medtronic ClosureFast™ procedure publications. Medtronic data on file, 2022.