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Important Safety Information

VenaSeal closure system and ClosureFast procedure

Important safety information

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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 http://manuals.medtronic.com

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

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ClosureFast™ endovenous radiofrequency (RFA) ablation cather

Reference statement:

Indications for use

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 this device to sale by or on the order of a physician.

ClosureRFS™ endovenous radiofrequency stylet

Reference statement:

Indications for use

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 this device to sale by or on the order of a physician.

ClosureRFG™ radiofrequency generator

Reference statement

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 the Operation Manual for a complete listing of indications, warnings, precautions safety notices, and operational information.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

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VenaSeal Procedure

Vein disease treatments

VenaSeal™
procedure

Minimally invasive nonthermal treatment for vein disease and varicose veins.

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Alert Important Safety Information
Young female in an exercise lunge pose with illustrated decorative elements

The VenaSeal procedure delivers a small amount of a specially formulated medical adhesive to seal — or close — the diseased vein, rerouting blood to nearby healthy veins and providing symptom relief. The VenaSeal closure system is a safe and effective treatment, offering significant improvement in quality of life.1-4

The VenaSeal procedure

Step 1: Catheter is placed in the vein

Using an ultrasound, your doctor will position a catheter into the diseased vein through a small access site.

Illustration showing how a catheter is placed in the vein during a VenaSeal procedure

Step 2: Specialized adhesive is placed

A specially formulated medical adhesive is placed in the diseased vein via a small catheter.

Illustration of VenaSeal adhesive being placed in the vein through a small catheter

Step 3: Light external pressure is applied

Light external pressure is applied to adhere the vein walls together. This step is repeated for the length of the vein.

Clinician's hand compressing a vein after a drop of VenaSeal medical adhesive has been inserted

Step 4: Catheter is removed

The catheter is removed and a single adhesive bandage is applied to the vein access site.

Illustration of small catheter being removed from the vein after a VenaSeal procedure
VenaSeal patient Heather jogging on grass

I had all the signs and symptoms — tired legs, restless leg syndrome, achiness, the unsightly bulges. The treatment went very, very smoothly. I was very comfortable. I would suggest it to anybody.

– Heather A., VenaSeal patient

Before the procedure

You will have an ultrasound imaging exam of the leg being treated. This exam is important for assessing the diseased superficial vein and planning the procedure.

During the procedure

Your doctor can discuss the procedure with you. Here is a brief summary of what to expect:

  • You may feel some minor pain or stinging with a needle stick to numb the site where the doctor will access your vein. 
  • Once the area is numb, your doctor will insert the catheter (i.e., a small hollow tube) into your leg. You may feel some pressure from the placement of the catheter.
  • The catheter will be placed in specific areas along the diseased vein to deliver small amounts of the medical adhesive. You may feel a mild sensation of pulling. An ultrasound will be used during the procedure to guide and position the catheter.

After the procedure

  • After treatment, the catheter is removed and a small adhesive bandage is placed over the puncture site.
  • You will be taken to the recovery area to rest.
  • Your doctor will recommend follow-up care as needed.

Patient results: before and after

Before VenaSeal procedure

Patient leg before VenaSeal procedure

Three months after VenaSeal procedure

Patient leg three months after VenaSeal procedure

Individual results may vary. Images courtesy of Dr. Kathleen Gibson.

VenaSeal results and testimonials

The VenaSeal procedure went very smoothly; there was no pain involved.

– Heather A., VenaSeal patient

My leg heaviness is gone, and I can walk 18 holes of golf again.

– Steve H., VenaSeal patient

Benefits of the VenaSeal procedure

  • Simple outpatient procedure
  • Lasting results, with a 94.6% closure rate at five years1
  • Compression stockings may not be needed after the procedure2,3
  • Faster recovery time than thermal ablation1,2
  • Less pain and bruising than thermal ablation1,2
  • No tumescent anesthesia

Possible complications of the VenaSeal procedure may include allergic reaction, inflammation, phlebitis, deep vein thrombosis, and/or pulmonary embolism. Talk to your doctor about the risks and benefits.

Type of therapy
Closure with medical adhesive (permanent implant)

Inpatient or outpatient procedure
Outpatient procedure

One- versus two-leg treatment:
Typically, both legs can be treated in the same appointment

Needle sticks required
One needle stick for vein access

Typical post-treatment recovery
Typically limited to healing of vein access site; some patients may experience temporary skin and tissue irritation

Compression hose
Not required, but your doctor may recommend it post-procedure

Procedure success rate
94.6% closure rate at five years1

VenaSeal procedure FAQ

Expand All

Is the VenaSeal procedure painful?

Most patients feel little, if any, pain during the outpatient procedure.1

When can I return to normal activity?

When will my symptoms improve?

Is there bruising after the VenaSeal procedure?

What happens to the VenaSeal procedure adhesive?

How is the VenaSeal procedure different from thermal energy procedures?

Is the VenaSeal procedure covered by insurance?

Find a vein disease doctor or clinic near you.

Enter your ZIP code to find a doctor who uses Medtronic VenaSeal or ClosureFast™ procedure treatments.

References

1

Morrison N, Gibson K, McEnroe S, et al. Randomized trial comparing cyanoacrylate embolization and radiofrequency ablation for incompetent great saphenous veins (VeClose). J Vasc Surg. April 2015;61(4):985–994.

2

Proebstle T, Alm J, Dimitri S, et al. Three-year follow-up results of the prospective European Multicenter Cohort Study on Cyanoacrylate Embolization for treatment of refluxing great saphenous veins. J Vasc Surg Venous Lymphat Disord. March 2021;9(2):329–334.

3

Almeida JI, Javier JJ, Mackay EG, et al. Thirty-sixth-month follow-up of first-in-human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. J Vasc Surg Venous Lymphat Disord. September 2017;5(5):658–666.

4

Morrison N, Gibson, Vasquez M, et al. VeClose trial 12-month outcomes of cyanoacrylate closure versus radiofrequency ablation for incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord. May 2017;5(3):321–330.

Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.

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