CardioSolv Ablation Technologies, Inc. has developed and aims to commercialize a simulation-based approach for non-invasive prediction of the optimal targets of catheter ablation in patients with infarct- related ventricular tachycardia. Successful completion of the commercialization will result in a major paradigm shift in the clinical procedure of ventricular tachycardia ablation, where accurate prediction of the optimal targets of ablation in each patient heart will be carried out by CardioSolv?s methodology prior to the clinical procedure. Guided by these predictions, delivery of ablation will be swift and precise, eradicating all infarct-related ventricular tachycardias with minimum lesion sizes. This will result in a dramatic improvement in the efficacy of and tolerance for the therapy, as well as in reduction of post- procedure complications.
The aim of this project is to complete a clinical trial to collect data in support of safety, efficacy, and labeling claims, with the ultimate goal of regulatory clearance to market the device.

Public Health Relevance

Each year 210k people in the US alone survive their first heart attack, and over half of these survivors will develop ventricular tachycardia (VT), a life-threatening heart rhythm, within their lifetime. The survivors that live with VT have a poor quality of life and high mortality. CardioSolv Ablation Technologies Inc. is has developed a patient-specific simulation-guided methodology for guiding doctors to place precise ablation lesions in the heart that eliminate VT, leading to dramatic improvements in outcomes, longevity, and quality of life for patients while reducing costs and improving access to care. The proposed work will move this technology to the cusp of regulatory clearance to market, within reach of finally delivering the promised benefits to patients.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44HL124901-04A1
Application #
9752191
Study Section
Special Emphasis Panel (ZHL1)
Program Officer
Tinsley, Emily
Project Start
2014-08-01
Project End
2022-05-31
Budget Start
2019-06-01
Budget End
2020-05-31
Support Year
4
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Cardiosolv Ablation Technologies, Inc.
Department
Type
DUNS #
079109378
City
Baltimore
State
MD
Country
United States
Zip Code
21218