Healthcare Professionals

ClosureFast Procedure

SUPERFICIAL VEIN THERAPIES

OVERVIEW

The ClosureFast™ procedure utilizes 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 and proven across multiple studies1,2 and patients.


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

The ClosureFast procedure eliminates the need for groin surgery and general anesthesia, and is generally performed using local anesthesia in a vein specialist’s office or an outpatient surgical facility. The procedure takes approximately 45-60 minutes and most patients typically spend two to three hours at the medical facility due to normal pre- and post-treatment procedures.

Consistent and Controlled

The ClosureFast catheter’s segmental approach eliminates the need for continuous pull-back of the energy source, allowing for controlled and repeatable radiofrequency ablation.

Optimal Therapeutic Power

Radiofrequency ablation delivers a lower heat gradient of energy at around 120°C. In contrast, some laser treatments can reach temperatures of over 700°C during the procedure.

ClosureFast Procedure Video

Learn more about the ClosureFast Procedure and see how it works.
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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.

PROVEN OUTCOMES

ClosureFast Procedure Before and After

*Individual results may vary.

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

Over 2 million patients have been treated with the ClosureFast procedure in over 100 countries around the world.

5-year study results1,2*

  • 94.9% reflux-free rate
  • 91.9% occlusion rate
  • VCSS: Reduction in mean score from 3.9 to 1.3
  • Pain: Increase in percentage of patients free of pain from 41.4% to 92.4%

Treatment with the ClosureFast catheter resulted in high closure rates with improvements in CEAP class grading and VCSS out to 5 years post-treatment.


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

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

Proebstle, T.M., Alm, B.J., Gockeritz, O., et al. Three Year European Follow-up Endovenous Radiofrequency Thermal Ablation of the Great Saphenous Vein With or Without Treatment of Calf Varicosities. J Vasc Surg. 2011;54(1)146-52.