INDICATIONS, SAFETY, AND WARNINGS VenaSeal Closure System and ClosureFast System


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 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, allergic reactions to cyanoacrylates, such as hives, asthma, hay fever and anaphylactic shock, arteriovenous fistula, bleeding from the access site, deep vein thrombosis (DVT), edema in the treated leg, embolization, including pulmonary embolism (PE), hematoma, hyperpigmentation, infection at the access site, non-specific mild inflammation of the cutaneous and subcutaneous tissue, pain, paresthesia, phlebitis, superficial thrombophlebitis, urticaria 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.


CLOSUREFAST SYSTEM

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.