BioSig Technologies Inc. has announced that clinical data acquired by its PURE EP System has been published in the Journal of Cardiovascular Electrophysiology.
The PURE EP 2.0 study was conducted at three US hospitals - Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Mayo Clinic Jacksonville, and Massachusetts General Hospital.
BioSig said intracardiac signal data of clinical interest were collected during 51 cardiac ablation procedures using the PURE EP System, the signal recording system, and the 3D mapping system at the same time stamps.
READ: BioSig to install PURE EP System for evaluation at St. Elizabeth’s Medical Center in Boston
The samples were randomized and subjected to blinded, head-to-head evaluation by three independent electrophysiologists to determine the overall quality and clinical utility of PURE EP signals when compared to conventional sources. Each reviewer responded to the same (235) signal comparisons using a 10-point rating scale.
BioSig said the results showed 93% consensus across the blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting PURE EP signals over the signals from conventional sources.
Further analysis of the responses from the blinded reviewers showed an 83% improved confidence when interpreting complex multi-component signals, leading to a better understanding of the catheter position in relation to the ablation target. Additionally, there was a 73% improved visualization of small, fractionated potentials increasing the proper analysis of scar and abnormal conduction tissue characteristics.
“In order for any new medical technology to be widely adopted and accepted, strong, prospective clinical study results are necessary,” said BioSig CEO Kenneth Londoner in a statement. “The results from the PURE EP 2.0 study clearly validate the clinical importance of our technology and position the Company for continued growth and success. We are grateful for the many physician investigators and research staff who participated in this study and look forward to continuing our clinical work to advance the field of electrophysiology and bioelectronic medicine.”
To date, over 60 physicians have completed over 1,400 patient cases with the PURE EP System across 13 clinical sites.
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