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Volta Medical has announced an extension of the product label for Volta AF-Xplorer in the United States.

Updated Labeling for Volta Medical's Volta AF-Xplorer System Now Available in the U.S.

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Volta Medical expands the U.S. label for its Volta AF-Xplorer device
Volta Medical expands the U.S. label for its Volta AF-Xplorer device

Volta Medical has announced an extension of the product label for Volta AF-Xplorer in the United States.

### Revolutionary AI-Driven Treatment for Persistent Atrial Fibrillation

Recent advancements in the treatment of persistent atrial fibrillation (AF) have seen a significant shift towards the integration of artificial intelligence (AI) in electrophysiology procedures. The Volta AF-Xplorer system, developed by Volta Medical, is leading this charge.

#### Key Updates for the Volta AF-Xplorer System

- **Label Expansion**: In June 2025, Volta Medical expanded the US labeling of the AF-Xplorer system to include data from the TAILORED-AF trial. This update provides physicians with FDA-recognized clinical evidence supporting the system's use in persistent AF cases. - **AI-Driven Guidance**: The AF-Xplorer system offers real-time, AI-driven insights during catheter ablation procedures, enabling electrophysiologists to make more patient-specific decisions. This is particularly beneficial for persistent AF, which is difficult to treat and accounts for the majority of AF cases, yet only about one-third of ablations target this advanced disease state.

#### TAILORED-AF Trial Outcomes

The TAILORED-AF trial, published in *Nature Medicine*, was a multicenter randomized controlled study comparing standard-of-care pulmonary vein isolation (PVI) to AI-guided, tailored ablation using the AF-Xplorer. In the modified intention-to-treat (mITT) population, 88% of patients in the tailored treatment arm were free from AF at 12 months, compared to 70% with standard PVI (p<0.0001).

#### Level-One Evidence

Volta claims that the AF-Xplorer is the first system in electrophysiology to demonstrate level-one evidence (from a randomized controlled trial) of improved efficacy outcomes specifically for persistent AF patients.

#### Broader Impact and Access

- **Regulatory Milestone**: The FDA’s inclusion of the Volta AF-Xplorer on its list of AI-enabled medical devices underscores regulatory recognition of its role in advancing AF care. - **Clinical Adoption**: The updated labeling and robust trial data are expected to broaden access and adoption of the AF-Xplorer system in the US, potentially improving outcomes for a large, challenging patient population.

#### Summary Table: TAILORED-AF Trial Results

| Treatment Approach | AF-Free at 12 Months | Significance | |----------------------------|----------------------|-----------------------| | Standard PVI (control) | 70% | Baseline | | AI-Guided Ablation (AF-Xplorer) | 88% | p < 0.0001 |

#### Conclusion

The Volta AF-Xplorer system, with its AI-driven guidance, represents a major advancement in the management of persistent atrial fibrillation, offering significantly improved outcomes over traditional approaches. The recent label expansion and publication of the TAILORED-AF trial results provide strong clinical and regulatory support for this technology, marking a new standard in personalized, evidence-based AF care.

Volta Medical is a health technology company focused on treating complex atrial fibrillation patients using AI solutions.

  1. The health tech industry has witnessed a significant shift in the treatment of atrial fibrillation (AF), with artificial intelligence (AI) playing an increasingly prominent role.
  2. Electrophysiology procedures are now seeing the integration of AI, driven by advancements in health tech.
  3. The Volta AF-Xplorer system, developed by Volta Medical, is leading this revolution in AF treatment.
  4. In June 2025, Volta Medical expanded the US labeling of the AF-Xplorer system, citing data from the TAILORED-AF trial.
  5. This update provides physicians with FDA-recognized clinical evidence supporting the system's use in persistent AF cases.
  6. The Volta AF-Xplorer system offers real-time, AI-driven insights during catheter ablation procedures.
  7. These insights enable electrophysiologists to make more patient-specific decisions during complex AF treatments.
  8. Persistent AF, which accounts for the majority of AF cases, is a challenging condition to treat, and only about one-third of ablations target this advanced disease state.
  9. The TAILORED-AF trial, published in Nature Medicine, was a multicenter randomized controlled study comparing standard-of-care pulmonary vein isolation (PVI) to AI-guided, tailored ablation using the AF-Xplorer.
  10. In the modified intention-to-treat (mITT) population, 88% of patients in the tailored treatment arm were free from AF at 12 months, compared to 70% with standard PVI.
  11. Volta Medical claims that the AF-Xplorer is the first system in electrophysiology to demonstrate level-one evidence (from a randomized controlled trial) of improved efficacy outcomes specifically for persistent AF patients.
  12. The FDA’s inclusion of the Volta AF-Xplorer on its list of AI-enabled medical devices underscores regulatory recognition of its role in advancing AF care.
  13. The updated labeling and robust trial data are expected to broaden access and adoption of the AF-Xplorer system in the US.
  14. This potential improvement in outcomes could benefit a large patient population facing persistent AF, a significant medical-condition.
  15. The TAILORED-AF trial results provide strong clinical support for the Volta AF-Xplorer system.
  16. The AI-driven guidance offered by the AF-Xplorer represents a major advancement in the management of persistent atrial fibrillation.
  17. Volta Medical is a leading company in the health tech sector, focused on treating complex atrial fibrillation patients using AI solutions.
  18. Persistent AF treatment via the AF-Xplorer system offers significantly improved outcomes over traditional approaches.
  19. This technology marks a new standard in personalized, evidence-based AF care.
  20. Science continues to play a crucial role in the development of innovative health tech solutions for various medical-conditions, including chronic diseases like AF.
  21. Moreover, advancements in sleep, eye-health, hearing, digestive-health, and skin-care are also being driven by the synergy between science and health tech.
  22. Alongside medical-conditions, the health tech industry is also making strides in workplace-wellness, fitness-and-exercise, mental-health, and sexual-health.
  23. Interestingly, the health tech sector is also addressing autoimmune-disorders, such as rheumatoid arthritis and lupus, using AI-driven therapies-and-treatments.
  24. Furthermore, health tech solutions are being applied to address the impact of climate-change on respiratory-conditions, cardiovascular-health, and neurological-disorders.
  25. The integration of AI in manufacturing processes if facilitating the production of medical devices, contributing to better healthcare.
  26. Beyond medicine, the health tech industry is making an impact in areas like personal-finance, banking-and-insurance, real-estate, and venture-capital.
  27. The health tech landscape is also transforming careers in the industry, from entrepreneurs and researchers to pharmacists and nurses.
  28. As the health tech sector continues to evolve, it's important to promote diversity-and-inclusion, particularly in leadership roles and small-business ventures.

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