Volta Medical Expands U.S. Labeling for AF-Xplorer with TAILORED-AF Trial Insights

Volta Medical Expands U.S. Labeling for AF-Xplorer System

Volta Medical, a pioneering healthcare technology company, has recently made headway in treating the underserved population afflicted by atrial fibrillation (AF). The firm announced a significant enhancement in the U.S. labeling of their flagship product, the Volta AF-Xplorer system, which integrates crucial data from the pivotal TAILORED-AF clinical trial. This advancement substantiates the system's capabilities and supports physicians in making better treatment decisions for patients suffering from complex AF.

The Importance of AF-Xplorer

The AF-Xplorer harnesses the power of artificial intelligence (AI) to provide real-time, patient-specific insights to electrophysiologists during catheter ablation processes. This improves decision-making, particularly for patients with persistent AF, a complex condition that comprises around 75% of individuals diagnosed with AF. Despite its prevalence, only a mere third of all catheter ablations are administered to these patients, leaving many in the shadows of this debilitating disease.

Significant Trial Results

The TAILORED-AF trial represents a monumental leap in electrophysiology. This multicenter, randomized controlled trial evaluated the effectiveness of a personalized ablation strategy using the Volta AF-Xplorer system. Notably, the results demonstrated that 88% of patients receiving the tailored treatment were free from AF after 12 months, compared to just 70% of those subjected to standard care protocols, a difference that is highly statistically significant (p<0.0001). These findings confirm that the Volta AF-Xplorer has become the first electrophysiological device to provide level one evidence of improved treatment outcomes for persistent AF.

Leadership's Commitment

Theophile Mohr Durdez, CEO and co-founder of Volta Medical, emphasized the importance of this label expansion, stating, "This label expansion is an important step for Volta Medical, and for millions of patients living with persistent AF. Clinical evidence now supports that Volta AF-Xplorer can assist physicians in improving outcomes for a vast and challenging arrhythmia population." This statement underscores the company's commitment to enhancing the quality of care for patients afflicted with AF.

Understanding Atrial Fibrillation

Atrial fibrillation is characterized by an irregular heartbeat, which can lead to serious health complications such as blood clots, stroke, and heart failure. Approximately 33 million people globally are living with AF, many of whom remain unaware of the condition's severity. Risk factors include untreated AF double the risk of heart-related deaths and increase chances of stroke by five times.

Further Information on TAILORED-AF

The TAILORED-AF study not only showed improved outcomes with the tailored approach but also reported a 66% success rate in achieving acute AF termination during procedures utilizing the AF-Xplorer system. The data collected thus far supports the hypothesis that personalized treatment strategies are advantageous in managing persistent AF. Moreover, although some secondary endpoints did not achieve statistical significance, the results remain promising for the tailored approach to patient care in AF treatment.

About Volta Medical

Founded in 2016 in Marseille, France, Volta Medical aims to revolutionize cardiac arrhythmia management through intelligent AI-driven medical devices. The Volta AF-Xplorer serves as a digital companion equipped to aid cardiologists in identifying abnormal electrograms during procedures, and it is FDA 510(k) cleared as well as CE marked in Europe. The company is dedicated to raising awareness and improving management among the AF patient community through initiatives like the “AI for AF” program.

For more details about the AF-Xplorer and the latest updates, please visit AI for AF.

Overall, the expansion of the U.S. labeling for the AF-Xplorer underscores the commitment of Volta Medical to enhance treatment approaches and provide better patient outcomes in the challenging landscape of atrial fibrillation management.