Important information regarding Philips aSV devices

Current patients should be evaluated and a discussion about whether to discontinue ASV therapy should occur if a current patient is found to be in the at-risk population. If it is unknown whether a current patient falls within the at-risk population, the patient should be evaluated to determine if ASV therapy should continue.

Do not place new patients with symptomatic chronic heart failure (NYHA 2-4) and reduced LVEF≤45%, AND moderate to severe predominant central sleep apnea on ASV therapy. Before putting patients on ASV, each patient should be assessed for Heart Failure. In case of signs and symptoms of Heart Failure an objective assessment of LVEF should be performed.

ADDENDUM – ANZCDACC Advisory Notice 5th September 2013 Device: Boston Scientific: COGNIS Implantable Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and TELIGEN DR & VR Implantable Cardioveter-Defibrillators (ICDs)

10th October 2014

Addendum to ANZCDACC Advisory Notice 5th September 2013

In addition to the original advisory below

Device: Boston Scientific: COGNIS Implantable Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and TELIGEN DR & VR Implantable Cardioveter-Defibrillators (ICDs) Manufactured prior to December 2009