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A New Multimodal Ablation Catheter for Treating Cardiac Arrythmias

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43HL149145-01
Agency Tracking Number: R43HL149145
Amount: $348,400.00
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): 2019-09-23
Award End Date (Contract End Date): 2020-09-22
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) 687-8701
Business Contact
Phone: (607) 687-8701
Research Institution

Atrial fibrillationAFis the most common type of cardiac arrhythmia affecting up toof the population with a higher occurrence in the elderlyThe first line treatment for AF is antiarrhythmia drugsYet there are many side effects to these drugs and the recurrence rate of AF while patients are being treated with these drugs is well documentedThe second level treatment is generally accepted as some form of thermal ablation that includes radio frequency ablationRFAor cryoablationThe former is often apoint by pointprocedure that can take a long time to accomplish successfully and can be technically challengingwhereas currently the most common cryoablation application is aCryoballoondesigned such that there is a circumferential zone that achieves pulmonary vein isolationPVIYet each of these thermal modalities is associated with a variety of problems such as phrenic nerve palsymore commonly associated with Cryoballoonand issues of unintentional heat spreadRFAcausing damage to neighboring non targeted tissueCPSI Biotech is a medtech company specializing in thermal ablation devices designed for the clinical marketThe Company s strategy is to develop and patent the technology and then license the intellectual property to largeglobal medical device companiesCPSI s products include the Super Critical NitrogenSCNand Pressurized Sub cooled NitrogenPSNcryo engines currently designed for mono thermal cryoablation of select tissues including those of the heartbladderesophaguskidney and pancreas among othersCPSI is currently developing a spot catheter cryoprobe designed to treat ventricular tachycardiaa first of its kind NIH supported technologyThis Phase I proposal focused on AF is the second chapter of CPSI s cardiac business strategy formulated to engineer additional devices for treating arrhythmias through the development of a mono therapy cryoablation catheterICEolateandmore importantlya new Dual Thermal AblationDTAheat and colddeviceICEolate DTAto treat AFICEolate DTA will be a multifunctional lasso tipped catheter that can both heatlike RFAand or freeze tissue from a single catheter deviceThis technology will also enable application of advanced ablation protocols which utilize the application of both heat and freeze in tandemThe advantages of the ICEolate DTA are several not the least of which is the ability to use heat followed by cold so that the heat spread into neighboring tissue can be controlled and quenched while at the same time more heat can be used for more effective and longer lasting PVIThe Specific Aims are the followingDevelop ICEolate and ICEolate DTA lasso ablation cathetersTest the efficacy of the ICEolate catheters in an ex vivo modelEvaluate the ICEolate catheters in pilot animal studiesIn summarythe intent of this feasibility Phase I project is to design a unique DTA lasso ablation catheterThe resulting ICEolate technology will be superior to RFA and Cryoballoons given its design and DTA capabilities leading to improved thermal ablation PVI procedures for treating AF resulting in fewer risks to patients This application proposes to develop a novel dual thermal ablation catheter and strategy for the treatment of cardiac arrhythmias

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

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