Design of a Test Protocol for Implantable Defibrillators

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$99,850.00
Award Year:
1995
Program:
SBIR
Phase:
Phase I
Contract:
1 R43 HL53822-01A1,
Agency Tracking Number:
29507
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
Ann Arbor Biomedical
13 Eastbury Ct, Ann Arbor, MI, 48105
Hubzone Owned:
N
Socially and Economically Disadvantaged:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
David Pelowitz
() -
Business Contact:
() -
Research Institution:
n/a
Abstract
Electrical 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.

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