Intended Use
The TriageHF feature can be used with commercially available Medtronic CRT-D, CRT-P, and ICD devices that have the OptiVol Fluid Status Monitoring feature. The indications for use of these devices do not change.
The TriageHF feature gives physicians another source of information to use in managing their patients. It does not replace assessments that are part of standard clinical practice or override recommended guidelines for treatment of heart failure patients. Clinicians should not rely exclusively on the TriageHF information to assess a patient’s heart failure risk. The TriageHF information is available to clinicians who monitor their device patients on the Medtronic CareLink Network.
Contraindications
There are no known contraindications for the use of TriageHF information.
See the device manual for detailed information regarding the intended use, contraindications, warnings, precautions, and potential complications/adverse events. For further information, call Medtronic Technical Services at (800) 328-2518 and/or consult Medtronic’s website at medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.