OMNI II Programmer - Cardiac contractility modulation system programmer

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Tillgänglig från:

Impulse Dynamics (Australia) Pty Ltd

Klass:

Class III

Tillverkad av:

Impulse Dynamics NV Schottegatweg Oost 10 Unit AIK, Curacao, Dutch Caribbean Netherlands

Terapiområde:

47467 - Cardiac contractility modulation system programmer

Terapeutiska indikationer:

Used to interrogate & program the OPTIMIZER IVs IPG using a Programming Wand placed directly over the implant site.The Programming Wand communicates via telemetry with the implanted IPG.The software runs on a laptop connected to a Programmer Interface box. In conjunction with the OPTIMIZER IVs IPG the programmer can log IPG activity, store, upload & download such log files to/from a remote, dedicated server & reprogram therapy parameters including ?safe mode? parameters in case of emergency. As part of the Optimizer IVs System, the OMNI II Programmer System, communicates with the Optimizer IVs Implantable Pulse Generator (IPG) via telemetry to record device data. The Optimizer IVs System is indicated for use in patients who are older than 18 years of age with symptomatic heart failure due to systolic left ventricular dysfunction despite appropriate medical therapy. The Optimizer IVs IPG delivers non-excitatory CCM signals to the heart and has no pacemaker or ICD functions.

Bemyndigande status:

A

Tillstånd datum:

2015-06-05