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VenaSeal closure system and ClosureFast procedure
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.
The ClosureFast™ endovenous radiofrequency ablation (RFA) catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.
The ClosureFast catheter is contraindicated for use in patients with thrombus in the target vein segment.
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.
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.
The ClosureRFS™ stylet is intended for use in vessel and tissue coagulation, including treatment of incompetent (i.e., refluxing) perforator and tributary veins.
The ClosureRFS stylet is contraindicated for use in patients with thrombus in the vein segment to be treated.
The potential complications include, but are not limited to, the following: arteriovenous fistula, infection, phlebitis, skin burns, hematoma, nerve damage, pulmonary embolism, and thrombosis.
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.
The ClosureRFG generator is used with radiofrequency catheters intended for vessel and tissue coagulation.
Refer to the applicable radiofrequency catheter instructions for use for a list of contraindications related to a ClosureFast system procedure.
Refer to the applicable radiofrequency catheter instructions for use for a list of potential complications related to a ClosureFast system procedure.
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.
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.