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CARDIOVASCULAR
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HeartMate 3 LVAD Reported ICD Experience

Experience indicates that certain models of implantable cardiac defibrillators (ICDs) and certain implantable pacemakers (IPMs) may, in some cases, not be able to establish telemetry and be reprogrammed due to electromagnetic interference when used with the HeartMate 3™ LVAS.

In such cases the ICDs or IPMs have continued to function properly and only their ability to communicate with the programmer was affected. The HeartMate 3 LVAS complies with applicable electromagnetic compatibility standards and is not influenced by such devices. No such difficulties have been reported with models other than those listed below.

Difficulty or inability to communicate with the ICD or IPM programmer has been reported for or may occur with the following manufacturer families:

Manufacturer Family / Model
Biotronik Acticor/Rivacor
Biotronik Ilivia Neo/Intica Neo
Biotronik Ilivia/Intica/Inlexa
Biotronik Itrevia/Iperia/Inventra
Biotronik Iforia/Ilesto/Idova
Biotronik Lumax
ELA Medical (Sorin) Paradyme CRT
Medtronic Cardia CRT
Boston Scientific ORIGEN CRT

This device is commercially available for use in select international markets.

MAT-2105186 v1.0

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DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.