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Radiofrequency ablation catheter being withdrawn from a vein as it collapses after treatment with heat

Catheter withdrawn, closing vein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.