Alert Indications, Safety, and Warnings

ClosureFast™ RFA System Radiofrequency Ablation for
Chronic Venous Insufficiency (CVI)

The ClosureFast™ procedure, with its patented overlap design, is the only RFA procedure with published long-term clinical data demonstrating safety and efficacy, with a 91.9% closure rate at 5 years.1,2

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Alert Indications, Safety, and Warnings

Overview


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Gap-free thermal ablation

The ClosureFast™ RFA system delivers uniform heat for lasting vein closure.1

  • Patented segmental procedure
  • Tumescent anesthesia
  • Less pain and bruising than laser energy treatment3
  • Post-procedure compression stockings required1
Disposable catheter inserted into a vein during the ClosureFast procedure

Catheter inserted into vein

Radiofrequency ablation catheter collapsing a vein with heat

Controlled heat collapses vein

Radiofrequency ablation catheter being withdrawn from a vein as it collapses after treatment with heat

Catheter withdrawn, closing vein

Product Details

ClosureFast™ Procedure Animation

ClosureFast™ endovenous radiofrequency ablation procedure

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.1,2

Both 3 cm and 7 cm heating elements provide an overlap of 0.5 cm as the device is repositioned.

Illustration of the 0.5 cm overlap of thermal treatment segments in the ClosureFast procedure

Note: Catheter also available with 3 cm heating element and 2.5 cm markings.

Clinical Evidence

ClosureFast™ Clinical Evidence

Building long-term evidence with high clinical standards

See More Clinical Evidence
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Indications

The ClosureFast™ endovenous radiofrequency ablation (RFA) catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux. The catheter is provided sterile, and is a single-use, disposable device. This catheter cannot be adequately cleaned and/or sterilized by the user in order to facilitate safe reuse, and is therefore intended for single use. Attempts to clean or sterilize these devices may result in a bio-incompatibility, infection, or product failure risks to the patient.

System Components 

ClosureFast™ Endovenous Radiofrequency Ablation Catheter

ClosureFast radiofrequency ablation catheter on light blue gradient background
  • The ClosureFast™ catheter precisely heats a 7 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™ Endovenous Radiofrequency Ablation Stylet

ClosureFast radiofrequency ablation stylet on light blue gradient background
  • The ClosureRFS™ stylet is the only 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 catheter.

ClosureFast™ Radiofrequency Generator

ClosureFast generator on light blue gradient background
  • The ClosureRFG™ generator delivers radiofrequency energy to the ClosureFast™ catheter and the ClosureRFS™ stylet for the effective treatment of CVI.
  • The controlled feedback mechanism monitors intravascular heat parameters in real time to automatically regulate therapeutic power.

Model Specifications

Catheter Model

CF7-7-60

CF7-7-100

CF7-3-60

Introducer Sheath
(minimum ID size)

7 F
(2.3 mm)

7 F
(2.3 mm)

7 F
(2.3 mm)

Insertable Length

60 cm

100 cm

60 cm

Heating Element Diameter

2.3 mm

2.3 mm

2.3 mm

Heating Element Length

7 cm

7 cm

3 cm

Heating Element Overlap

0.5 cm

0.5 cm

0.5 cm

 Compatible Guidewire

0.025"

0.025"

0.025"

Maximum Power Setting

40 W

40 W

18 W

Default Target Temperature Setting

120°C

120°C

120°C

Software Version: RFG2

4.0.0 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

Additional Resources

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VenaSeal™ Closure System

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References

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

ClosureFast and ClosureFast RFS Patents. Medtronic data on file, 2022.

3

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.

4

Morrison N, Gibson K, Vasquez M, et al. 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

Medtronic ClosureFast Procedure Publications. Medtronic data on file, 2019.

6

ClosureFast Procedures. Medtronic data on file, 2019.