![]() 1843 Michigan Street, P.O. Box 678, Sturgeon Bay, WI 54235 Phone (920) 746-1060 ~ Fax (920) 746-1072 |
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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: 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. |
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This information is not intended as a substitute for professional medical care. |
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