Volta Medical Featured in Latest Consensus Statement from Leading International Cardiac Electrophysiology Societies on Atrial Fibrillation Ablation

• Published in the EP Europace Journal, the consensus statement highlights Volta’s AI Companion and the TAILORED-AF clinical trial.

Marseille (France), May 9, 2024 – Volta Medical, a pioneering health technology company developing artificial intelligence (AI) solutions to assist electrophysiologists, today announced that the company’s AI companion technology and the TAILORED-AF clinical trial have been featured in the latest consensus statement released by leading global cardiac electrophysiology societies. This statement focuses on advancements in managing catheter and surgical treatments for atrial fibrillation (AF). Volta’s AI companion is a software solution designed to assist electrophysiologists in real-time assessment of dispersed electrograms (EGMs). The TAILORED-AF clinical trial was designed to determine if a tailored AI software-guided ablation procedure in combination with pulmonary vein isolation is superior to a conventional anatomical ablation procedure. Clinical results will be published soon and shared with the scientific community.    

"We are proud that Volta’s spatio-temporal dispersion-guided AI solution is included in the latest consensus statement on atrial fibrillation ablation. Particularly, the document describes the TAILORED-AF trial protocol and its anticipated impact on clinical practice. Acknowledgement of our TAILORED-AF trial by leading experts in the field validates our relentless dedication to empowering physicians with innovative solutions and driving transformative progress in healthcare.” said Dr. Jérôme Kalifa, MD, PhD, Volta Medical Chief Medical Officer and co-founder.

The 2024 European Heart Rhythm Association (EHRA)/Heart Rhythm Society (HRS)/Asia Pacific Heart Rhythm Society (APHRS)/Latin American Heart Rhythm Society (LAHRS) expert consensus statement on catheter and surgical ablation of atrial fibrillation represents results from a detailed survey that was sent to all members, a comprehensive literature search and the evaluation of existing evidence. The compiled list of clinical advice was then voted on by the authors, all proposed recommendations were only included if voting results were at least 80% in support. The consensus statement is intended to provide physicians with information to promote optimal care that is aligned with the latest advancements and consensus within the field. The statement has been published in EP Europace Journal (PMCID: PMC11000153)¹, the journal of the European Society of Cardiology and the European Heart Rhythm Association.

About Atrial Fibrillation
The American Heart Association (AHA) defines atrial fibrillation (AF) as a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications.²  Approximately 33 million patients worldwide are living with AF.^3,4 Even though untreated AF doubles the risk of heart-related deaths and is associated with a 5-fold increased risk for stroke, many patients are unaware that AF is a serious condition.

About the TAILORED-AF Trial
TAILORED-AF is an international, multicenter, randomized controlled trial designed to determine if a tailored AI software-guided ablation procedure targeting areas of spatio-temporal dispersion in combination with pulmonary vein isolation (PVI) is superior to a conventional anatomical ablation targeting PVI alone for the treatment of persistent AF. The primary endpoint of the study is the absence of documented AF episodes > 30 seconds, with or without anti-arrhythmic drugs (AADs), 12 months after a single index ablation procedure. Secondary endpoints include absence of AF and/or atrial tachycardia (AT) episodes after a 12- month period, following one or more procedures, as well as safety. Volta Medical expects results from the TAILORED-AF trial in 2024.

About Volta Medical
Volta Medical is a health tech company developing artificial intelligence software solutions created to assist cardiac electrophysiologists during arrhythmia treatment procedures to improve clinical outcomes for patients. Founded by three physicians and a data scientist in 2016 and based in Marseille, France, the company’s mission is to improve cardiac arrhythmia management by developing state-of-the-art, data-driven medical devices trained on large databases of procedural data. The Volta AF Xplorer™ is a digital AI companion designed to assist electrophysiologists with real-time identification of specific abnormal electrograms (EGMs) known as spatio-temporally dispersed EGMs during AF and atrial tachycardia procedures. The AF-Xplorer has been engineered for versatility and its use has been demonstrated with the most popular AF mapping and recording systems, as well as with the most common ablation modalities. The company has obtained U.S. FDA 510(k) clearance and European CE Mark approval for its innovative products. For more information, visit the company’s website at www.volta-medical.com.

Volta Contact
Jeff Martin, SVP of Global Marketing
Volta Medical
jeffrey.martin@volta-medical.com

European Media Contact
Brittney Sojeva
MC Services AG
Volta-medical@mc-services.eu

References
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1. Europace. 2024 Apr; 26(4): euae043. Published online 2024 Apr 8. DOI: 10.1093/europace/euae043
2. https://www.heart.org/en/health-topics/atrial-fibrillation [last accessed June 9, 2023]
3. Colilla S, Crow A, Petku W, Singer DE, Simon T, Liu X. Estimates of current and future incidence and prevalence of atrial fibrillation in the U.S. adult population. Am J Cardiol 2013; 112:1142–1147. DOI: 10.1016/j.amjcard.2013.05.063
4. https://kompetenznetz-vorhofflimmern.de/en [last accessed June 9, 2023]