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System for Transmural Ablation of Atrial Fibrillation

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43HL154847-01
Agency Tracking Number: R43HL154847
Amount: $296,728.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NHLBI
Solicitation Number: PA19-272
Solicitation Year: 2019
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-09-28
Award End Date (Contract End Date): 2021-03-31
Small Business Information
Saratoga, CA 95070-4017
United States
DUNS: 078482797
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 (818) 618-4764
Business Contact
Phone: (818) 618-4764
Research Institution

Project SummaryAtrial fibrillation (AF) is the most common arrhythmia that increases the risk of a stroke while impairing the
patient’s quality of life and costing US around $6.65 billion per year 6. Despite advances in the field, the current
treatments have limited success rate especially in patients with longstanding AF with enlarged atria that requires
multiple procedures with higher costs, inconvenience, and separate recovery of 2 time-consuming procedures
that do not guarantee fully transmural lesions (arrhythmia treatment through the tissue thickness) since the
epicardial (outside surface of the heart) and endocardial (inside surface of the heart) lesions are performed at
2 separate sittings and not well-aligned. Our proposed approach uses a self-aligning bipolar ablation system
that includes a thoracoscopically guided epicardial delivery system and a flexible endocardial catheter following
it across myocardium. This allows for simultaneous epicardial and endocardial tissue contact for the purpose of
continuous bipolar ablation in a single procedure in a shorter time and higher treatment success rate.Therefore, we have developed a self-aligning technology which allows epicardial and endocardial ablation
to be performed simultaneously in a single procedure, increasing transmurality, and decreasing the time and
expense of the 2 procedures. Thus far, we have demonstrated 1- smooth catheter movement across the tissue.
2- successful transmural lesion sets in our ex vivo and in vivo open chest studies across the porcine atrial wall
experiments.Phase I funding will enable us to optimize and prototype this paired endo- and epi- catheter system that is
inserted via a conventional transseptal and thoracoscopic approach, respectively. This minimally invasive system
will be capable of smooth movement, consistent contact force with tissue along the ablation path independent of
tissue thickness, and transmural ablation along the atrial wall.Narrative
Over five million people in the U.S. suffer from abnormal heart rhythms that increases their risk of stroke (5
fold) while impairing their quality of life and costing US around $6.65 billion per year. At present, only a small
fraction of people are offered curable ablation therapy because of recurrence after initial treatment. The
EpiEndoAF device provides a minimally invasive solution to treat such patients with high success and play a
major role in improving outcomes in these patients.

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

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