Superficial vein
ClosureFast™ radiofrequency ablation (RFA) system
<p>The ClosureFast™ procedure uses radiofrequency energy to treat patients with superficial vein disease.</p>
Overview
Data are from ClosureFast™ 7F studies. ClosureFast™ 6F catheter is designed to provide the same outcomes as established by ClosureFast™ 7F catheter.
Catheter inserted
into vein
Controlled heat
collapses vein
Catheter withdrawn,
closing vein
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.
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.
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.
ClosureFast™ system catheter
| 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.
† Compared to ClosureFast 7F catheter and Venclose catheter in bench testing.
‡ Bench test data on file at Medtronic. N = 15 Venclose catheters and 30 each ClosureFast 6F and 7F catheters. Bench tests may not be indicative of clinical performance.
- 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. February 2015;102(3):212–218.
- 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. June 2009;20(6):752–759.
- 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. November 2020;8(6):978–989.
- ClosureFast Procedures. Medtronic data on file, 2024.
- Medtronic ClosureFast Procedure Publications. Medtronic data on file, 2022.