19
Indications for Use - USA
The Indications for Use listed below have clearance within the USA for the following models of ZOLL IVTM
®
Thermal Regulation Systems:
•
The Thermogard XP
®
These systems can be used with any of the IVTM Catheters. The indications for use are specific to the catheter.
Please refer to the Indications for Use statement in the catheter specific Instructions for Use.
Indications for Use – Cool Line Catheters
The ZOLL IVTM Thermal Regulation System using the Cool Line
®
Catheter is indicated for use in fever reduc-
tion, as an adjunct to other antipyretic therapy, in patients with cerebral infarction and intracerebral hemor-
rhage who require access to the central venous circulation and who are intubated and sedated.
Indications for Use – All Other Catheters
The ZOLL IVTM Thermal Regulation System, using one of the Icy
®
, Quattro
®
or Solex 7
®
model catheter, is
indicated for use:
•
in cardiac surgery patients to achieve and or maintain normothermia during surgery and recovery/intensive
care, and
•
to induce, maintain and reverse mild hypothermia in neurosurgery patients in surgery and recovery/inten-
sive care.
Warning—Fever Reduction
The safety of this device has not been demonstrated for fever reduction in patients presenting with sub-
arachnoid hemorrhage or primary traumatic brain injury. The safety and effectiveness of this device was
examined in a random-ized controlled trial of 296 patients. The mortality results reported in this trial, for
the four patient cohorts enrolled, are presented in the table below (CI – cerebral infarction, ICH – intrace-
rebral hemorrhage, PTBI – primary traumatic brain injury, SAH – subarachnoid hemorrhage).
Cool Line
Control
n
N
%
n
N
%
p-value
1
1. Fischer’s exact test
CI
3
16
18.8
3
14
21.4
0.74
ICH
8
33
24.2
7
27
25.9
1.00
PTBI
10
44
22.7
4
38
10.5
0.24
SAH
13
61
21.3
7
63
11.1
0.15
For more details on the results of this study please refer to Physician’s Manual – “Normothermia for the
Neuro-critically Ill Stroke Patient” P/N 600248.
Summary of Contents for IVTM
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