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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

This is an image of the catheter that is inserted in a vein during the ClosureFast™ radiofrequency ablation procedure.

Controlled heat
collapses vein

This is an image of the ClosureFast™ radiofrequency ablation catheter collapsing a vein with heat.

Catheter withdrawn,
closing vein

This is an image of the ClosureFast™ radiofrequency ablation catheter being withdrawn from a vein as it collapses after heat treatment.

Product details

Proven procedure, lower profile

The ClosureFast™ radiofrequency ablation catheter is now available in 6F, designed for†‡:

  • Enhanced flexibility
  • Improved navigation
  • Increased kink resistance

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

This is an illustration of a catheter showing an overlap of 0.5 cm at each thermal treatment segment during the ClosureFast™ radiofrequency ablation procedure.

1. 8 cm ablation

2. 0.5 cm overlap

3. 8 cm ablation

Note: 3 cm (7F) heating length available for shorter segments.

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Clinical evidence

91.9%

closure at 5 years1

94.9%

reflux-free rate at 5 years1

72%

improvement in VCSS scores at 5 years4

3 M+

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. 

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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.
This is an image of the ClosureFast™ endovenous radiofrequency ablation catheter.

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.
This is an image of the ClosureFast™ endovenous radiofrequency ablation stylet.

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.
This is an image of the ClosureFast™ endovenous radiofrequency ablation generator.

Adverse events may include hematoma, phlebitis, skin injury, nerve injury, thrombophlebitis, thrombosis, and/or pulmonary embolism.

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Ordering information

ClosureFast™ system catheter (global region)

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 (global region)

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
CLFKITTP Full procedure pack with tumescent tubing set
EU-CLF-KITAC-TP Procedure pack — blue tray, introducer needle, long green needle, blue trolley wrap, ultrasound probe cover, introducer sheath, (3) ultrasound gel, guidewire, tumescent tubing set
EU-CPP-7F Procedure pack including guidewire, tray, needle, tray wrap, probe cover, (2) rubber bands, (2) label trolley cover packs, patient label, introducer, aquasonic gel sachet, guidewire
497847 Micro introducer set — Argon branded, 7 Fr x 11 cm
10100/30409 Kimal tubing for tumescent pump — Nouvag DP20 or DP30
1501COV Pedal for tumescent pump — Nouvag DP30
4180- Nouvag pump DP30 without pedal
4187 Nouvag pump DP30 with pedal
6022COV Nouvag tubing set — quantity: pack of 10

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.

  1. 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.
  2. 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.
  3. ClosureFast and ClosureFast RFS Patents. Medtronic data on file, 2022.
  4. 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.
  5. ClosureFast Procedures. Medtronic data on file, 2024.
  6. Medtronic ClosureFast Procedure Publications. Medtronic data on file, 2022.