VOLTA MEDICAL Reports VX1 AI Software Now FDA Cleared

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December 9, 2020

Volta Medical, a pioneering French-based HealthTech startup is pleased to announce that it has obtained FDA clearance for its revolutionary VX1 AI software.

Volta Medical states this is the first FDA clearance for an AI based tool in interventional cardiac electrophysiology. VX1 is a machine and deep learning-based algorithm designed to assist operators in the real-time manual annotation of 3D anatomical and electrical maps of the human atria during atrial fibrillation (AFib) or atrial tachycardia.

These annotations help physicians locate heart regions harboring a specific electrogram abnormality, known as spatiotemporal dispersion. This innovative detection and patient-specific localization of abnormal regions may eventually help physicians better decide where they need to intervene to either burn (radiofrequency) or freeze (cryotherapy) faulty electrical pathways.

According to Seth H. Goldbarg, MD, FACC, FHRS, Director of Cardiac Electrophysiology, New York-Presbyterian/Queens, Assistant Professor, Weill Cornell Medical College, Flushing, NY, USA, “AFib represents a major challenge in cardiology due to the complexities associated with identification, localization, and treatment of the pathological zones that cause and perpetuate this abnormal heart rhythm. The current standard of care does not provide us with a uniform, easy to follow and predictable approach to identify these regions. This has led to heterogenous approaches to treating these patients, with very mixed and often disappointing results. We are excited to be part of the further studies taking place with this AI software, as the VOLTA system may provide a major step forward in the effective approach to ablation of persistent AFib.

Conventional ablation methods, while useful for treating patients, who cannot tolerate or who are resistant to anti-arrhythmic drug therapy, have so far been less precise in persistent AFib patients than desired. Their results, even if significant in certain cases, remain sub-optimal. Localization and ablation of drivers perpetuating AFib has been at the forefront of cardiovascular disease research but has not led to any radical changes to-date. The Volta mapping system is intuitive, user-friendly and shows promise to potentially reduce inter-operator variability in the analysis of procedural data without lengthening either the diagnostic or therapeutic procedures.

The VX1 system holds enormous promise for offering an easier, faster, more accurate and reliable way to identify zones of interest in patients who suffer from chaotic heart muscle contractions. Developed jointly by top experts in the fields of electrophysiology and digital technologies, VX1 is simple to use. It bears the potential to provide a permanent solution to a chronic health burden with a one-time breakthrough procedure and has the potential to become the gold standard AI solution, for efficient and affordable cardiac ablation procedures.

For Jérôme Kalifa, MD and co-founder of Volta Medical, “Our ultimate goal is to offer an alternative to a lifetime of medication that can have problematic side effects in some patients, while bringing a better quality of life to those who suffer from bothersome daily disease symptoms. This is what is generating increasing enthusiasm around the potential of our solution. The recently obtained FDA clearance is an important milestone for our company and ultimately for patients who suffer from difficult to treat forms of AFib.

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