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Safety Summary
As with any medical procedure, the Closure® procedure
is not suitable for all people and there are associated risks and
considerations. You should consult your physician to determine if
the Closure procedure is right for you and any special risks your
individual condition may present.
Indications:
The Closure System is intended for endovascular coagulation of
blood vessels in patients with superficial venous reflux.
Contraindications:
Patients with thrombus in the vein segment to be treated.
PRECAUTION: For the patients with a pacemaker, internal defibrillator or other active implanted device, consult the cardiologist and the manufacturer of the active implanted device. Continuous patient monitoring during the procedure is recommended. Evaluate the patient and the implanted active device post procedure. Keep all power cords and the attached sterile cable away from the location of the pacemaker or leads, defibrillator or the implanted active device.
CAUTION: In patients with an aneurysm in the vein segment to be treated, the vein wall may be thinner in the area of the aneurysm. To effectively occlude a vein with an aneurysmal segment, additional tumescent infiltration may be needed over the aneurysmal segment, and the treatment of the vein should include segments proximal and distal to the aneurysmal segment.
CAUTION: No data exists regarding the use of this catheter in patients with documented peripheral arterial disease. The same care should be taken in the treatment of patients with significant peripheral arterial disease as would be taken with a traditional vein ligation and stripping procedure.
Potential Risks & Complications:
- Potential complications include, but are not limited to the following: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, paresthesia, skin burns.
- Treatment of veins located very close to the skin surface may result in a skin burn.
- Paresthesia is higher with treatment at or below the calf.
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