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High Frequency Dielectric Sensing Cardiac Radio Frequency Ablation Monitoring and Lesion Assessment System

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43HL147787-01
Agency Tracking Number: R43HL147787
Amount: $224,522.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NHLBI
Solicitation Number: PA18-574
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-05-01
Award End Date (Contract End Date): 2021-01-31
Small Business Information
Columbia, MD 21044-4909
United States
DUNS: 079939983
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (410) 338-8000
Business Contact
Phone: (305) 725-8105
Research Institution

Atrial fibrillationAFibaffects aboutmillion individuals in the USA and is a significant cause of morbidity and mortalityPercutaneous catheter intracardiac Radio Frequency AblationRFAtreatment of AFib requires contiguous transmural lesions between anatomical boundaries for effective durable electrical isolationCurrent procedures have arecurrence rateprobably due to incomplete ablations and carry arisk of complicationsprimarily due to excessive RF energy depositionCurrentlythere are no methods for intraoperative assessment of lesion formation and tissue characterization during intracardiac RFAThere is a clinical need for a system which will intraoperativelyquantify electrical contact between electrode tissuecharacterize tissue in electrode contactdistinguish ablated v s non ablated tissueto identify gaps ablation lesionsconfirm and assess lesion formation e glesion depthextent of ablationandmonitor rate of RF energy deposition in the tissue to enable titrate energy deposition in tissuethus enable create contiguous transmural lesions safelyTo address this clinical needwe have designed and prototyped an intraoperative High Frequency Dielectric Sensing RFA Monitoring and Lesion Assessment systemHFDS RFALASOur solution involvesdesigning the ablation electrode of an RFA catheter as aminiature antennato monitor the electrical properties of the tissue adjacent to the antenna electrodeThe system comprisesaablation catheter with an antenna electrode sensorbvector network analyzer to measure tissue dielectric properties in a frequency range ofMHz toGHzcRF filter hardware to filter ablationKHzand measurementMHz GHzfrequencies and duser interface display to guide the procedure and monitor and assess lesion formationTo demonstrate proof of conceptwe prototyped an RFA catheter with a front sensing antenna electrodeband selective RF filters and tested the system in swinenlesionsBy monitoring the high frequency reflection impedance electrical propertiesHFRIEPsof the antenna electrodethe system intraoperatively monitors procedure parameterscharacterizes tissue and assesses lesion formation with high certainty and accuracyTo advance this technology towards a clinical productduring Phase I of this SBIR projectwe will design and prototype a HFDS RFA LAS system comprising anFr steerable RFA catheter with an omnidirectional antenna electrode sensorcomplete with saline flush irrigation and thermocouples and a high fidelity RF filter hardware to enable simultaneously ablatesense and track catheter using clinical navigation and ablation hardwareThe system will be tested in bench top tests and in animalsnswineto quantitatively demonstrate feasibility of intraoperatively monitoring procedure parameterscharacterizing tissue and assessing lesion formation Atrial fibrillation is a significant cause of morbidity and mortalitypercutaneous cardiac catheter radio frequency ablation is used to treat atrial fibrillationbut its main limitation is high recurrence rate due to inability of intraoperatively assessing lesion formation and distinguishing ablated from non ablated tissueWe propose to develop and commercialize a novel high frequency dielectric sensingHFDSablation monitoring and lesion assessment system which will enable intraoperatively monitor procedure parametersdistinguish tissue typesconfirm and assess lesion formation and enable titrate RF power to prevent collateral injuryThe HFDS system has the potential to significantly improve RFA outcomes by reducing recurrence rates and preventing collateral injurywith a consequent impact on associated health care costs and quality of life for patients

* Information listed above is at the time of submission. *

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