Design of a Test Protocol for Implantable Defibrillators
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Ann Arbor Biomedical
13 Eastbury Ct, Ann Arbor, MI, 48105
AbstractElectrical management of potentially lethal arrhythmias has been found to dramatically improve survcandidates at risk of sudden cardiac death. Over 40,000 Implantable cardioverter/defibrillators (ICDsince initial FDA approval in 1985. False positive delivery of shock remains a major problem and newdesigned with more sophisticated arrhythmia detection schemes and tiered-therapy protocols. We willstandardize testing and device evaluation for future devices. Such a system will assess sensitivityalgorithms and device response to yield reliable statistics on safety and efficacy. In Phase l we wifeasibility of designing a tandardized test for exercising the arrhythmia detection mechanisms contvariety of both simulated and clinical experimental data. We will 1) complete the development of a catrial and ventricular events which can mimic any cardiac arrhythmia, and determine device response;proprietary test set of clinical data previously recorded during electrophysiology studies, as a comtraining set which has been made available by us to commercial designers of implantable devices; andprotocol utilizing both simulated and experimental signals for evaluation of next-generation devicecategories as oversensing, undersensing, errors in rhythm diagnosis, errors in pacing therapy and/or
* information listed above is at the time of submission.