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U.S. Expansion of Certification for Volta Medical's Volta AF-Xplorer Device

U.S. Labelling Update for Volta Medical's Volta AF-Xplorer System Announced

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U.S. Expansion of Label Approval for Volta AF-Xplorer by Volta Medical
U.S. Expansion of Label Approval for Volta AF-Xplorer by Volta Medical

U.S. Expansion of Certification for Volta Medical's Volta AF-Xplorer Device

In a significant development for the treatment of persistent atrial fibrillation (AF), the Volta AF-Xplorer, a leading AI-enabled medical device, has made strides following the results of the TAILORED-AF trial. Volta Medical, a health technology company specializing in treating complex AF patients with AI solutions, has recently expanded the US labeling of its flagship Volta AF-Xplorer system to include clinical data from this landmark study [1][2].

The TAILORED-AF trial was a prospective, multicenter randomized controlled study comparing standard pulmonary vein isolation (PVI) treatment with AI-guided, patient-specific catheter ablation using the Volta AF-Xplorer system. The study demonstrated significantly improved long-term outcomes: 88% of patients treated with the tailored AI-guided ablation were free from atrial fibrillation at 12 months, compared to 70% of patients receiving standard care (p<0.0001) [1].

This success is particularly important as persistent AF is one of the most challenging arrhythmias to treat and represents the majority of AF patients. However, only about one-third of catheter ablations are performed on persistent AF cases with standard methods. The Volta AF-Xplorer system uses real-time AI-driven insights to enable more personalized decision-making during ablation procedures, addressing this unmet need effectively [1].

Volta Medical claims that the Volta AF-Xplorer is the first electrophysiology system to demonstrate level-one evidence of improved efficacy outcomes specifically for persistent AF, bolstered by the TAILORED-AF results [1]. This clinical evidence has facilitated an expanded FDA labeling, which should help broaden US clinical access to AI-guided ablation for persistent AF patients [2][5].

Meanwhile, the field of cardiology continues to evolve with new developments. Abbott, a prominent player in the industry, has received CE mark for the Volt Pulsed Field Ablation System, a new system designed for AF treatment [3]. However, unlike the Volta AF-Xplorer, there's no claim that the Volt Pulsed Field Ablation System has demonstrated level one evidence of improved efficacy outcomes for persistent AF patients.

In summary, the Volta AF-Xplorer system currently stands as a leading AI-enabled medical device for treating persistent AF, backed by robust, randomized controlled trial data that have led to regulatory recognition and expanded clinical adoption in the United States [1][2]. This advancement offers hope for the millions of patients living with persistent AF, a condition that until now has been among the most challenging cardiac arrhythmias to treat effectively.

References: [1] Volta Medical. (2022). TAILORED-AF trial results. Retrieved from https://www.volta-medical.com/tailored-af-trial-results/ [2] Volta Medical. (2022). Volta AF-Xplorer receives FDA label expansion. Retrieved from https://www.volta-medical.com/volta-af-xplorer-receives-fda-label-expansion/ [3] Abbott. (2022). Abbott receives CE mark for Volt Pulsed Field Ablation System. Retrieved from https://www.abbott.com/about-abbott/news-media-center/press-releases/abbott-receives-ce-mark-for-volt-pulsed-field-ablation-system.html [4] American Heart Association. (2020). Atrial Fibrillation. Retrieved from https://www.heart.org/en/health-topics/atrial-fibrillation [5] FDA. (2022). Volta AF-Xplorer. Retrieved from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/product_classification.cfm?ID=K182571

  1. The health tech industry witnessed a significant advancement with the Volta AF-Xplorer, an AI-enabled medical device, making strides in the treatment of persistent atrial fibrillation (AF).
  2. Volta Medical, a company specializing in health tech, has expanded the US labeling of its flagship Volta AF-Xplorer system.
  3. The TAILORED-AF trial, a prospective, multicenter randomized controlled study, compared standard pulmonary vein isolation (PVI) treatment to AI-guided, patient-specific catheter ablation using the Volta AF-Xplorer system.
  4. The study demonstrated significantly improved long-term outcomes, with 88% of patients treated with AI-guided ablation being free from AF at 12 months, compared to 70% of patients receiving standard care.
  5. Persistent AF, one of the most challenging arrhythmias to treat, is the focus of the Volta AF-Xplorer system, as only about one-third of catheter ablations are performed on persistent AF cases with standard methods.
  6. The Volta AF-Xplorer system uses real-time AI-driven insights to enable more personalized decision-making during ablation procedures.
  7. Volta Medical claims that the Volta AF-Xplorer is the first electrophysiology system to demonstrate level-one evidence of improved efficacy outcomes specifically for persistent AF.
  8. The TAILORED-AF results have facilitated an expanded FDA labeling, which should help broaden US clinical access to AI-guided ablation for persistent AF patients.
  9. Meanwhile, the field of cardiology continues to evolve, with Abbott receiving CE mark for the Volt Pulsed Field Ablation System, a new system designed for AF treatment.
  10. Unlike the Volta AF-Xplorer, there's no claim that the Volt Pulsed Field Ablation System has demonstrated level-one evidence of improved efficacy outcomes for persistent AF patients.
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