Setpoint Endovascular Temperature Probe

FDA-Cleared Indications

• Use in patients who require controlled regulation of core body temperature.
• Use with a percutaneous catheter placed in the venous system to facilitate endovascular temperature management.

Clinical Applications

• Controlled core-temperature management in patients requiring active temperature regulation.
• Induction or maintenance of a prescribed patient temperature under hospital-based clinical supervision.

Reported off-label uses

• Targeted temperature management after cardiac arrest when use is outside the device's specific labeling or institutional protocol.
• Temperature management in selected patients with acute neurologic injury, such as stroke or traumatic brain injury, when not specifically covered by the labeling.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• The catheter must be compatible with the available venous access site, insertion equipment, and temperature-management console.
• Placement requires sterile technique and imaging or other appropriate clinical guidance, with attention to venous injury, infection, thrombosis, bleeding, and malposition.
• Available catheter sizes and configurations should be confirmed in the current manufacturer instructions for use; the record provided does not specify the full size range.
• MRI safety and conditional-use requirements should be verified in the current device labeling before MRI. Do not assume the probe or connected console is MRI safe.
• Use is contraindicated or limited when venous access is unsafe or when the patient's condition makes catheter placement, anticoagulation, or active temperature manipulation inappropriate.