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Indications, Safety & Warnings

Indications, safety, and warnings

Superficial vein products

Quick links to products

VenaSeal Closure System

Intended Use/Indications

The VenaSeal closure system (VenaSeal system) is indicated for use in the permanent closure of lower extremity superficial truncal veins, such as the great saphenous vein (GSV), through endovascular embolization with coaptation. The VenaSeal system is intended for use in adults with clinically symptomatic venous reflux as diagnosed by duplex ultrasound (DUS).

Contraindications

Separate use of the individual components of the VenaSeal closure system is contraindicated. These components must be used as a system. The use of the VenaSeal system is contraindicated when any of the following conditions exist: previous hypersensitivity reactions to the VenaSeal™ adhesive or cyanoacrylates, acute superficial thrombophlebitis, thrombophlebitis migrans, acute sepsis.

Potential Adverse Effects of the Device on Health

The potential adverse effects (e.g., complications) associated with the use of the VenaSeal system include, but are not limited to, adverse reactions to a foreign body (including, but not limited to, nonspecific mild inflammation of the cutaneous and subcutaneous tissue), arteriovenous fistula, bleeding from the access site, deep vein thrombosis (DVT), edema in the treated leg, embolization, including pulmonary embolism (PE), hematoma, hyperpigmentation, hypersensitivity or allergic reactions to cyanoacrylates, such as urticaria, shortness of breath, and anaphylactic shock, infection at the access site, pain, paresthesia, phlebitis, superficial thrombophlebitis, urticaria, erythema, or ulceration may occur at the injection site, vascular rupture and perforation, visible scarring.

Instructions for use can be found in the product labeling at manuals.medtronic.com.

Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician.

ClosureFast Endovenous Radiofrequency (RFA) Ablation Catheter

Intended Use/Indications

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

Contraindications

The ClosureFast catheter is contraindicated for use in patients with thrombus in the target vein segment.

Potential Adverse Effects of the Device on Health

The potential complications include, but are not limited to, the following: adjacent nerve injury, hematoma, pulmonary embolism, thrombosis, infection, phlebitis, skin burn or discoloration, and vessel perforation.

Important: Please reference the Instructions For Use (IFU) for a complete listing of indications, contraindications, warnings and precautions, adverse effects, and suggested procedure.

Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician.

ClosureRFS Endovenous Radiofrequency Stylet

Intended Use/Indications

The ClosureRFS™ stylet is intended for use in vessel and tissue coagulation, including treatment of incompetent (i.e., refluxing) perforator and tributary veins.

Contraindications

The ClosureRFS stylet is contraindicated for use in patients with thrombus in the vein segment to be treated.

Potential Adverse Effects of the Device on Health

The potential complications include, but are not limited to, the following: arteriovenous fistula, infection, phlebitis, skin burns, hematoma, nerve damage, pulmonary embolism, and thrombosis.

Important: Please reference the Instructions For Use (IFU) for a complete listing of indications, contraindications, warnings and precautions, adverse effects, and suggested procedure.

Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician.

ClosureRFG Radiofrequency Generator

Indications for Use

The ClosureRFG generator is used with radiofrequency catheters intended for vessel and tissue coagulation.

Contraindications

Refer to the applicable radiofrequency catheter instructions for use for a list of contraindications related to a ClosureFast system procedure.

Potential Adverse Effects of the Device on Health

Refer to the applicable radiofrequency catheter instructions for use for a list of potential complications related to a ClosureFast system procedure.

Important: Please reference to the Operation Manual for a complete listing of indications, warnings, precautions, safety notices, and operational information.

Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician.

UC201907929-01c EN

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Closurefast™ radiofrequency ablation (RFA) system

Proven procedure
Lower profile

The ClosureFast RFA system is now available in 6F for better flexibility and easier navigation, even in tortuous veins.†‡

Alert Indications, Safety, and Warnings

Now in 6F, designed for†‡:

Illustration of the ClosureFast™ radiofrequency ablation catheter showing flexibility in a tortuous vein

Enhanced flexibility

Illustration of the ClosureFast™ radiofrequency ablation catheter navigating through a value in the vein

Improved navigation

Illustration of the ClosureFast™ radiofrequency ablation catheter showing kink-resistance as it travels through a tortuous vein

Increased kink resistance

Trusted technology

Built on technology you know and trust.

See the data
Decorative element

2.5 M+

patients treated.1

Decorative element

200+

published articles and clinical studies.2

Decorative element

91.9%

closure at 5 years.3

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

Data are for ClosureFast 7F catheter.

Distinct design

We're committed to evidence and innovation.

Our new ClosureFast 6F catheter builds on the RFA technology that's been trusted since 2006.

Technology and data overview

Joe Zygmunt, Medtronic portfolio advisor, talks about the history, clinical experience, and long-term performance of the ClosureFast procedure.

Why catheter design matters

Lead engineer Chuanjing Xu explains how the design of the new ClosureFast 6F catheter impacts performance — and what makes it unique.

The value of compression detection

Engineer John Elhard describes the feedback loop between the ClosureFast catheter and generator and how it provides real-time information to the physician.

Patented overlap design

Engineer Sarah Thole talks about the value of the ClosureFast system’s patented gap-free technology for thermal ablation.

Patient impact

A story of resilience

After losing a leg to phlebolymphedema, Iona’s doctor performed the ClosureFast procedure to help save her remaining leg and restore mobility — and hope.

“I may have lost a leg, but I gained a life.” – Iona

Results may vary. Talk to your doctor for more information.

Physician experience

Three highly experienced ClosureFast RFA users share their experience with flexibility and navigation using the new ClosureFast 6F catheter.

Read the article
Portrait of Karem Harth, M.D.

Karem Harth, M.D.,
MHS, RPVI
Cleveland, Ohio

Portrait of Misaki Kiguchi, M.D.

Misaki Kiguchi, M.D.,
M.B.A., FACS
Washington, D.C.

Portrait of Raghu Kolluri, M.D.

Raghu Kolluri, M.D., M.S.,
RVT, MSVM
Columbus, Ohio

Additional resources

*

™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

1

ClosureFast Procedures. Medtronic data on file, 2022.

2

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

3

Proebstle TM, Alm BJ, Göckeritz O, et al. Five-year results from the prospective European multi-centre cohort study on radiofrequency segmental thermal ablation for incompetent great saphenous veins. Br J Surg. 2015;102(3):212–218. ClosureFast 7F catheter used in this study.

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