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Development of an advanced cryothermal ablation catheter and method for treating cardiac arrhythmias

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43HL142319-01
Agency Tracking Number: R43HL142319
Amount: $300,100.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: R
Solicitation Number: PA17-302
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-09-21
Award End Date (Contract End Date): 2019-08-31
Small Business Information
Owego, NY 13827-1515
United States
DUNS: 150225337
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (607) 777-2775
Business Contact
Phone: (607) 687-8701
Research Institution

The need for the development of new strategies for treatment of cardiac arrhythmiasincluding
ventricular arrhythmiashas experienced a palpable increase in the last few yearsVentricular
ArrhythmiaVAor ventricular tachycardiaVTis a severe abnormal heart rhythm which can cause
death if not treated immediatelyVentricular FibrillationVFis the most serious form of VAVF is most
commonly caused by VT and is responsible forof sudden cardiac deathsSCDWhile several
treatment options are currently in use under investigationmany if not all remain suboptimalThis is
critical as it is estimated that SCD is responsible fordeaths in the US annuallyWhile various
treatment options currently exista number of issues have been reported including the high cost of
treatmentpatient discomfortorgan toxicity and incomplete treatment among othersAs such there is
an ever growing urgency and compelling need for the development of new strategies and devices to
treat VTThe intent of this project is to develop and characterize a new endovascular based
endocardial cryoablation treatment strategy and catheter systemICEolatefor the treatment of VTThis technology will enable the focalspotas well as linear ablation lesions and have the capability of
conducting electrical activity mappingincluding cryomappingof cardiac tissue prior to and following
ablationAdditionallythe technology will be used in conjunction with transesophageal echocardiogram
imaging which will enable direct visualization of lesion formationThe prototype unit and preliminary
data collected to date strongly support the potential of this approachThe major goals of this Phaseproposal are todevelop the ICEolate cathetertest this new treatment protocol in an ex vivo
tissue modelandconduct a pilot in vivo study to validate developmentThe successful completion
of this project will lead to a new minimally invasive endovascular based approach for the management
of VT and other cardiac arrhythmiasFurtherthis project will provide data in support of establishing
dose parameters necessary for optimal clinical application for the treatment of cardiac arrhythmiasOnce completedthis project will provide for an effectiveminimally invasive treatment option for
individuals suffering from VTcontributing to efforts for improving patient survival and quality of life This application proposes to develop a novel cryoablation strategy for the treatment of
ventricular tachycardia and other cardiac arrhythmias

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

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