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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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.