BioSig Technologies, Inc. (NASDAQ:BSGM) has revealed that scientific abstract has concluded that its PURE EP System is able to produce reliable and high-quality signals when compared to the available standard of care systems.
The abstract and poster, entitled 'A novel cardiac signal processing system for electrophysiology procedures: early insights from the PURE EP 2.0 study', will be available electronically from August 30 at the ESC Congress 2020 - The Digital Experience.
The medical technology company is developing a proprietary biomedical signal processing platform, the PURE EP System designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals. PURE EP System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.
READ: BioSig Technologies installs PURE EP System at Massachusetts General Hospital as part of clinical study
The group said the abstract is co-authored by Carola Gianni, M.D., Amin Al-Ahmad, M.D., Shane M. Bailey, M.D., G. Joseph Gallinghouse, M.D., Rodney P. Horton, M.D. and Andrea Natale, M.D. of the Texas Cardiac Arrhythmia Institute (TCAI) at St. David’s Medical Center in Austin, TX. The independent, blinded reviewers were Bradley P. Knight, M.D. (Northwestern University), Wendy Tzou, M.D. (University of Colorado), and Pasquale Santangeli, M.D. (University of Pennsylvania).
According to the abstract, identical electrocardiographic and intracardiac signal data were recorded during 15 atrial fibrillation ablation procedures from the PURE EP System, the signal recording system, and the 3D mapping system. The collected signals underwent blinded, controlled evaluation by three independent electrophysiologists to determine whether the PURE EP signals are a viable alternative to conventional sources and if it provides additional or clearer diagnostic information.
The reviewers were asked to record the quality of each signal sample on a scale of 1-10 and select a rationale for their rating in a dropdown menu. Based on the ratings for each pair of signals, a cumulative total of 29 PURE EP signals out of 34 (85.3%) were rated as statistically equivalent or better for this dataset. In 35.5% of samples, the reviewers selected PURE EP data because "more signal components were visible."
“BioSig Technologies is very pleased to see some of the early results from the PURE EP study shared during ESC 2020. We greatly appreciate the scientific collaboration with the team at TCAI and the independent EP reviewers. The PURE EP study is on-going, and we look forward to sharing multi-center data with the EP community in the coming months," Julie Stephenson, VP of Clinical Affairs at BioSig Technologies said in a statement.
The European Society of Cardiology (ESC) is an independent, non-profit organization whose members represents more than 95,000 men and women in the field of cardiology from Europe, the Mediterranean Basin, and far beyond. Due to the COVID-19 pandemic, the government in the Netherlands has banned all meetings until September 1, so as Amsterdam was to be the host city, it is no longer possible for ESC Congress to take place as planned, instead the online event is available at no charge, although pre-registration is required via here.
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