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Design of a Test Protocol for Implantable Defibrillators

Award Information

Department of Health and Human Services
Award ID:
Program Year/Program:
1995 / SBIR
Agency Tracking Number:
Solicitation Year:
Solicitation Topic Code:
Solicitation Number:
Small Business Information
Analogic Engineering, Inc.
P.O. Box 873 Guernsey, WY 82214
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Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
Phase 1
Fiscal Year: 1995
Title: Design of a Test Protocol for Implantable Defibrillators
Agency: HHS
Contract: 1 R43 HL53822-01A1,
Award Amount: $99,850.00


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

Principal Investigator:

David Pelowitz

Business Contact:

Small Business Information at Submission:

Ann Arbor Biomedical
13 Eastbury Ct Ann Arbor, MI 48105

Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No