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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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