Safety Summary

As with any medical intervention, potential risks and complications exist with the VNUS 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 VNUS Closure procedure is provided, you are encouraged to review these with your doctor at the time of consultation.

Indication:
The VNUS Closure System is intended for endovascular coagulation of blood vessels in patients with superficial venous 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, paresthesia, skin burn.
• Treatment of veins located very close to the skin surface may result in a skin burn.
• Paresthesia may occur from thermal damage to adjacent sensory nerves. The risk of paresthesia is higher with treatment at or below the calf.