| VNUS
Closure - 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 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, 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. |
