Volta Medical’s artificial intelligence (AI) solution demonstrated 83% freedom from atrial fibrillation (AF) at 12 months after a single procedure in patients with recurrent AF and isolated pulmonary veins following prior ablation
Volta Medical, committed to revolutionizing care for underserved complex AF patients with breakthrough AI solutions, announced results from the RESTART trial, published in Heart Rhythm. This study demonstrates positive outcomes for patients with recurrent AF and isolated pulmonary veins who underwent ablation using Volta’s AI solution.
The RESTART trial is the first prospective, multicenter study to evaluate the use of AI solutions on patients with recurrent AF despite confirmed durable pulmonary vein isolation. These patients have historically faced poor success rates with empirical strategies. By leveraging Volta Medical’s AI solution, RESTART demonstrates that even in this highly complex group, personalized, data-driven therapy has the potential to deliver improved outcomes. Key findings include:
“Patients with recurrent atrial fibrillation and isolated pulmonary veins represent one of the most frustrating populations we treat. Many of these patients have already undergone multiple procedures and are told there are no good options left.” Said Dr. John Hummel “The RESTART trial shows the potential of Volta’s AI solution.”
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. It is estimated that 7 million patients in the US are living with AF.45 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 advancing the use of AI to transform the treatment of complex cardiac arrhythmias. Founded in 2016 in Marseille, France, by three physicians and a data scientist, Volta’s mission is to improve outcomes for patients with AF by developing cutting-edge, data-driven solutions trained on vast procedural datasets.
The company’s flagship product, AF-Xplorer™ II, is a next-generation digital AI companion designed to assist electrophysiologists with the real-time identification of spatio-temporal dispersed electrograms (EGMs) during AF and atrial tachycardia procedures. Engineered for versatility, AF-Xplorer II integrates seamlessly with leading AF mapping and recording systems and is compatible with the most common ablation modalities. The solution is both U.S. FDA 510(k) cleared and European CE Marked.
To support awareness and education, Volta Medical created the AI for Persistent AF Care program to connect patients, caregivers, and providers with resources about AF and AI-guided treatment. For more information, visit www.aiforafib.com.
About Gilde Healthcare
Gilde Healthcare is a specialized healthcare investor managing €2.6 billion across two fund strategies: Venture&Growth and Private Equity. The Venture&Growth fund of Gilde Healthcare invests in fast growing companies active in therapeutics, medtech and digital health, based in Europe and North America. The Private Equity fund of Gilde Healthcare participates in profitable lower mid-market healthcare companies based in North-Western Europe. For more information, please visit www.gildehealthcare.com.
