In-Situ Lead Tester for Implantable Devices

Koronis Biomedical Technologies Corporat, Maple Grove MN

Investigators

Linked publications & trials

Abstract

DESCRIPTION (provided by applicant): 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.