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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 to discuss 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 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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