Koronis Biomedical Technologies (KBT) proposes a novel tool to test the integrity of implantable cardioverter- defibrillator (ICD) leads in-situ. Siilar to pacemakers, ICDs are surgically implanted just under the skin outside of the patient's rib cage. An ICD lead, which is a unified bundle of several insulated conductor cables, passes under the clavicle and through a vein to the chambers of the heart. While ICDs have been very effective at preventing sudden cardiac death, there have been repeated problems with ICD lead failures that have resulted in inappropriate shocks, failure to shock, ineffective cardioversion, and death. ICD leads fail over time and the longevity is difficult to predict and can be affected b the age and activity level of a patient. Early diagnosis of ICD lead anomalies is important to reduce morbidity and/or mortality from loss of pacing, inappropriate ICD shocks, and/or ineffective treatment of ventricular tachycardia or ventricular fibrillation. However, existing technology for diagnosis of lead anomalies has significant limitations and shortcomings. New tools are needed. A major goal of the proposed tester is the identification of lead anomalies at the subclinical stage, before they present as a clinical problem. The proposed testing tool will be initially applied intraoperatively during ICD replacement procedures and in the future integrated directly into ICDs. Phase 1 will model, simulate, develop, and evaluate a prototype tester. Phase 2 will develop a production prototype tester and undertake efficacy evaluations in humans.

Public Health Relevance

An implantable cardioverter-defibrillator (ICD) is a small battery-powered electrical impulse generator that is implanted in patients who are at risk of sudden cardiac death due to ventricular fibrillation and ventricular tachycardia. The device is programmed to detect cardiac arrhythmia and correct it by delivering a jolt of electricity. Implantable cardioverter defibrillators have demonstrated clear life-saving benefits.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43HL120529-01
Application #
8592804
Study Section
Special Emphasis Panel (ZRG1-SBIB-Y (12))
Program Officer
Baldwin, Tim
Project Start
2013-08-07
Project End
2014-08-06
Budget Start
2013-08-07
Budget End
2014-08-06
Support Year
1
Fiscal Year
2013
Total Cost
$213,597
Indirect Cost
Name
Koronis Biomedical Technologies Corporat
Department
Type
DUNS #
140696332
City
Maple Grove
State
MN
Country
United States
Zip Code
55369