Volta Medical today announced CE (Conformité Européenne) Mark according to the new European Medical Device Regulation MDR 2017/745 for its Volta AF-Xplorer™, an AI companion that is cleared in the United States for the real-time manual or automatic annotation of spatiotemporal dispersions during AF and atrial tachycardia (AT) procedures.
- Proprietary AI companion technology assists electrophysiologists by reducing ambiguity in mapped atrial fibrillation (AF) patterns
MARSEILLE, France, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Volta Medical a pioneering health technology company developing artificial intelligence (AI) solutions to assist electrophysiologists, today announced CE (Conformité Européenne) Mark according to the new European Medical Device Regulation MDR 2017/745 for its Volta AF-Xplorer™, an AI companion that is cleared in the United States for the real-time manual or automatic annotation of spatiotemporal dispersions during AF and atrial tachycardia (AT) procedures. Volta’s AF-Xplorer™ is the enhanced version of Volta’s VX1™ device. This major step will enable sales and distribution of the new product in the European Union (EU).
“We are pleased that Volta’s AF-Xplorer™ is now available in the EU to assist electrophysiologists in the treatment of patients with atrial fibrillation,” said Theophile Mohr-Durdez, Volta Medical CEO and co-founder. “The launch of AF-Xplorer™ will accelerate our growth in the EU market.” The Volta AF-Xplorer employs an algorithm powered by machine and deep learning, which has been trained on an extensive database of electrograms (EGMs). These EGMs have been meticulously annotated by expert electrophysiologists. This methodology facilitates a standardized approach to pinpointing what is known as spatiotemporal dispersed EGMs, a suspected source of AF.
TAILORED-AF, an international, multicenter, randomized controlled trial, comparing conventional pulmonary vein isolation to pulmonary vein isolation plus Volta’s guided ablation with Volta VX1™, enrolled 374 patients with persistent and long-standing persistent AF. Results from TAILORED-AF are expected later this year.
Volta’s AF-Xplorer™ also received U.S. Food and Drug Administration (FDA) clearance in January 2023 for the real-time manual or automatic annotation of spatiotemporal dispersions during AF and atrial tachycardia (AT) procedures.
“We are excited about the potential impact of AF-Xplorer™ for patients with persistent, drug-resistant AF,” said Dr. Tom De Potter, an electrophysiologist at OLV Hospital. “The AI companion offers a more personalized and precise approach by pinpointing optimal ablation locations in real time.”
VOLTA is currently enrolling patients in Re-Ablation Using a Tailored Approach Targeting EGM-Dispersion (RESTART), an interventional clinical trial to be conducted at sites across the US and select EU countries, evaluating the use of Volta’s AI companion solution in recurrent-AF patients who failed previous ablations.
About the TAILORED-AF Trial
TAILORED-AF is an international, multicenter trial designed to determine if a tailored VX1™ AI software-guided ablation strategy targeting areas of spatiotemporal dispersion in combination with pulmonary vein isolation (PVI) is superior to a conventional anatomical ablation strategy 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 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.1 Approximately 33 million patients worldwide are living with AF.2,3 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 Volta Medical
Volta Medical is a health technology company developing artificial intelligence software solutions with the aim of assisting cardiac electrophysiologists during arrhythmia treatment procedures to improve clinical outcomes for patients. Founded by three physicians and a data scientist in 2016 in Marseille, France, Volta’s overarching goal is to improve cardiac arrhythmia management by developing state-of-the-art, data-driven medical devices trained on large databases of procedural data. The company’s first product, VX1™, is a digital AI companion device and algorithm to assist cardiologists with real-time identification of specific abnormal electrograms (EGMs), known as spatiotemporal dispersed EGMs. Its second software iteration, Volta AF-Xplorer™ is now cleared for use in the US for the real-time manual or automatic annotation of spatiotemporal dispersion during AF and atrial tachycardia (AT) procedures and is CE Marked in the European Union. For more information, visit the company’s website at www.volta-medical.com.
U.S. Media Contact
Glenn Silver
Finn Partners
glenn.silver@finnpartners.com
Volta Contact
Jeff Martin, SVP of Global Marketing
Volta Medical
jeffrey.martin@volta-medical.com
References
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- https://www.heart.org/en/health-topics/atrial-fibrillation [last accessed June 9, 2023]
- 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
- https://kompetenznetz-vorhofflimmern.de/en [last accessed June 9, 2023]
