ClosureFast^™ Radiofrequency Ablation (RFA) System

for chronic venous Insufficiency (CVI)

The ClosureFast™ procedure uses radiofrequency energy to treat patients with superficial vein disease. Its segmental approach features an overlap of 0.5 cm at each treatment segment, designed to eliminate gaps in treatment.

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ClosureFast radiofrequency ablation system

Alert Indications, Safety, and Warnings

Overview

Technology you know and trust

Gap-free thermal ablation

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

Patented segmental procedure
Less pain and bruising than laser energy treatment²
Proven clinical results and rapid patient recovery^1,2

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

Catheter inserted into a vein during the ClosureFast procedure

Controlled heat
collapses vein

ClosureFast radiofrequency ablation catheter collapsing a vein with heat

Catheter withdrawn,
closing vein

ClosureFast radiofrequency ablation catheter being withdrawn from a vein as it collapses after treatment with heat

Product details

Proven procedure, lower profile

ClosureFast 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

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

8 cm ablation
0.5 cm overlap
8 cm ablation

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

Clinical evidence

91.9%

closure at 5 years¹

94.9%

reflux-free rate at
5 years¹

72%

improvement in VCSS scores at 5 years⁴

2.5 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 endovenous radiofrequency ablation (RFA) catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

System components

ClosureFast endovenous radiofrequency ablation catheter

The ClosureFast 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.

ClosureFast endovenous radiofrequency ablation stylet

The ClosureRFS™ 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 catheter.

ClosureFast 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.

ClosureFast endovenous radiofrequency ablation generator inside a green circle

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

Model specifications

Catheter model	CF6-8-60	CF6-8-100	CF7-7-60	CF7-7-100	CF7-3-60
Introducer sheath (min. ID size)	6F (2.0 mm)	6F (2.0 mm)	7F (2.3 mm)	7F (2.3 mm)	7F (2.3 mm)
Insertable length	60 cm	100 cm	60 cm	100 cm	60 cm
Heating element diameter	2.0 mm	2.0 mm	2.3 mm	2.3 mm	2.3 mm
Heating element length	8 cm	8 cm	7 cm	7 cm	3 cm
Max. power setting	40 W	40 W	40 W	40 W	18 W
Default target temp. setting	120 C	120 C	120 C	120 C	120 C
Software version: RFG2	4.0.0 or higher	4.0.0 or higher	4.0.0 or higher	4.0.0 or higher	4.4.0 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	0.025 in	0.025 in	0.025 in	0.025 in	0.025 in

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™*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.

References

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.

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.

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, 2022.

⁶

Medtronic ClosureFast Procedure Publications. Medtronic data on file, 2022.

ClosureFast™ Radiofrequency Ablation (RFA) System