Healthcare Professionals

ClosureFast Procedure

SUPERFICIAL VEIN THERAPIES

  • ClosureFast Procedure

OVERVIEW

The ClosureFast™ procedure utilizes patented, overlapping segmental radiofrequency ablation to deliver uniform heat to close the vein. Once sealed, blood is directed to nearby healthy veins. The ClosureFast procedure has been rigorously tested across multiple studies.1-3

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. These catheters 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.

PRODUCT DETAILS

DELIVER PATENTED PERFORMANCE

Gap-free Thermal Ablation

The ClosureFast™ RFA system is the only gap-free thermal ablation system with published long-term clinical data demonstrating safety and efficacy, with a 91.9% closure rate at 5 years.1,2

  • Patented, overlapping segmental procedure2
  • Tumescent anesthesia
  • Less pain and bruising than laser energy treatment3
ClosureFast Procedure Overview

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

ClosureFast Overlapping Procedure

Segmental treatment with ClosureFast™ catheter with 7 cm heating element

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ClosureFast Procedure Before and After

Individual results may vary.

Images courtesy of Jonathan Calure, M.D. of Maryland Vein Professionals.

GO GAP-FREE  FOR PATENTED PERFORMANCE

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

  • 250+ published clinical studies and articles4
  • Over 2 million patients have been treated with the ClosureFast procedure in over 100 countries around the world.5

5-year study results

ClosureFast 5-Year Outcomes

ClosureFast Procedure Video

Learn more about the ClosureFast Procedure and see how it works.
More information (see more) Less information (see less)

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TECHNICAL GUIDE

Instructions for Use
Find the technical guide in the product labeling supplied with each device or call Medtronic at 800-961-9055.

MODEL SPECIFICATIONS

ClosureFast Catheter

CLOSUREFAST ENDOVENOUS RADIOFREQUENCY ABLATION CATHETER

  • 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 Stylette

CLOSURERFS ENDOVENOUS RADIOFREQUENCY ABLATION STYLET

  • 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 Generator

CLOSURERFG RADIOFREQUENCY GENERATOR

  • 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.
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

7 cm

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
1

Proebstle, T.M., Alm, B.J., Gockeritz, 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;102:212-8.

2

ClosureFast and ClosureFast RFS Patents. https://www.medtronic.com/content/dam/medtronic-com/global/Corporate/meaningful-innovation/documents/CVG-Patent-Marking.pdf.pdf

3

Almeida JI, 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 Jun;20(6):752-9.

4

Medtronic ClosureFast Procedure Publications. Medtronic data on file. 2019

5

ClosureFast Procedures. Medtronic data on file. 2019.

6

Morrison, N. VeClose Extension Study Five-year Results. Presented at Charing Cross, April 16, 2019; London, UK.