baxter Starling - Patient Populations in Which the Starling Monitor Has Not Been Tested

©2020 Baxter International Inc. 2- 5
Indications for Use
Patient Populations in Which the Starling Monitor Has Not
Been Tested
Patient populations of specific interest in which the Starling Monitor has not been tested
include the following:
 Patients with congenital heart disease associated with complex intra-cardiac shunts.
 Patients with Continuous Flow LVADs: The Starling technology works by detecting pulsatile
changes in aortic blood volume. With a continuous flow LVAD, by definition, there are little
if any pulsations unless the heart itself ejects. Therefore, use of the Starling device in these
patients is not recommended.
Important
Any serious incident that has occurred in relation to the device should be reported to Baxter International
Inc. and the competent authority in the member state in which the user and/or patient is located.