Safety Summary 

As with any medical intervention, potential risks and complications exist with the Closure procedure.  You should consult your physician to determine if your individual condition presents any special risks.  Although a summary of potential complications of the Closure procedure is provided, you are encouraged to review these with your doctor at the time of the consultation. 

Indication:

The Closure System is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux. 

Contraindication:

Patients with thrombus in the vein segment to be treated. 

Potential Risks & Complications:

• Potential complications include, but are not limited to the following: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, paresthsia, skin burn.
• Treatment of veins located very close to the skin surface may result in a skin burn.
• Paresthesia may occur from the thermal damage to adjacent sensory nerves.  The risk of paresthesia is higher with treatment at or below the calf.

Caution:

Caution is advised if you have a pacemaker, internal defibrillator or other active implanted device; aneurismal section in the vein to be treated, or if you have documented peripheral arterial disease.  Consult your physician for more information.

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