Volta Medical Enters into Joint Development Agreement with GE HealthCare to Enhance Arrhythmia Procedures with AI-Driven Electrophysiology Technologies

Volta Medical Press Release

MARSEILLE, France, July 23, 2024 -- Volta Medical, a pioneering health technology company developing artificial intelligence (AI) solutions to assist electrophysiologists, today announced a Joint Development Agreement with GE HealthCare, a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator. Through this collaboration, Volta aims to integrate its latest AI solution, the Volta AF-Xplorer™, with GE HealthCare’s latest digital platform, Prucka™ 3 and CardioLab™ EP Recording system. The combined solutions are expected to enhance performance and streamline workflows for electrophysiologists during catheter ablation procedures to treat atrial fibrillation.

"Our mission to combat complex heart rhythm diseases relies on optimizing interoperability. Through this collaboration with GE HealthCare, we are advancing the frontier of current clinical applications in the field of electrophysiology," said Théophile Mohr-Durdez, CEO and co-founder of Volta Medical. “To help enhance patient care in this field, Volta Medical aims to further integrate its AI solution with EP innovators to help increase compatibility and address the challenges clinicians face in analyzing cardiac electrical signals.”

Volta Medical’s AI solution is designed to assist electrophysiologists in real-time assessment of dispersed electrograms (EGMs). This aligns with GE HealthCare's CardioLab™ EP Recording system’s signal clarity. In bringing these technologies together, the companies aim to help physicians optimize management of AFib by integrating advanced EP recording capabilities with AI-driven dispersion information.

"Access to vast amounts of data empowers clinicians in their decision-making, but effectively using this data at the point of care can be challenging," said Devon Bream, Global GM for Invasive Cardiology at GE HealthCare. "As GE HealthCare continues to advance our innovation to provide clinicians with precise signals in the EP lab, Volta Medical’s AI-driven solutions hold promise in consolidating and simplifying data, as well as assisting clinicians in making treatment decisions for their patients. I’m excited about our ongoing collaboration with Volta Medical as we work to innovate and transform electrophysiology labs to ensure patients receive the best possible care."

This collaboration marks one of Volta’s key initiatives following the Heart Rhythm Society 2024 meeting where investigators presented the positive TAILORED-AF trial results during the Late-Breaking Clinical Trial and Science sessions which demonstrated improved freedom from AF in patients treated with AI-guided ablation compared to conventional anatomical ablation. The company is now focusing on early commercialization efforts and the completion of the RESTART clinical trial, which is evaluating the use of Volta’s AI ablation solution in recurrent-AF patients who failed previous ablations and are now undergoing Volta-supported ablation.

About Atrial Fibrillation

The American Heart Association defines AFib 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 AFib.2,3 Even though untreated AFib doubles the risk of heart-related deaths and is associated with a 5-fold increased risk for stroke, many patients are unaware that AFib 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, 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 cardiologists with real-time identification of specific abnormal electrograms (EGMs) known as spatio-temporal 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.

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 trial is absence of documented AF episodes lasting longer than 30 seconds, with or without anti-arrhythmic drugs (AADs), 12 months after a single index ablation procedure. The trial met the primary endpoint by demonstrating superiority in patients assigned to the Tailored cohort compared to the Anatomical cohort. 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.

About the RESTART Trial

The RESTART clinical trial is an international, multicenter, non-randomized interventional study evaluating outcomes in recurrent-AF patients who failed previous ablations and who are now undergoing Volta AI assisted ablation, to assess if patients will be AF-free, without antiarrhythmic drugs, 12 months after their procedure. Enrollment for the trial is set at 92 patients.

References

1. https://www.heart.org/en/health-topics/atrial-fibrillation [last accessed June 9, 2023]

2. 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

3. https://kompetenznetz-vorhofflimmern.de/en [last accessed June 9, 2023]