Abbott secures early European approval for Volt PFA medical device

In the rapidly evolving electrophysiology market, major players such as Abbott, Boston Scientific, Medtronic, and Johnson & Johnson are driving advancements in Pulsed Field Ablation (PFA) systems. These innovative technologies offer a potentially safer treatment for Atrial Fibrillation (AFib), with less risk of injury to surrounding tissue compared to older ablation methods.

Abbott, for instance, has been active in developing its Volt system, though specific details about its PFA sector offerings are not widely available. The company is known for its EnSite X EP system, used for mapping and navigating during ablation procedures.

Boston Scientific, a leader in electrophysiology solutions, continues to invest in research and development (R&D) and strategic partnerships to strengthen its market presence. The company has seen success with its Farapulse PFA device, boosting its electrophysiology sales in 2024.

Medtronic is another key player, focusing on next-generation Radio Frequency (RF) ablation systems for cardiovascular applications. While specific PFA system updates may not be widely known, Medtronic's involvement in PFA is part of broader efforts to improve electrophysiology treatments.

Johnson & Johnson is also involved in the development of electrophysiology solutions, although its PFA advancements may not be as prominent as its other medical device offerings. The company maintains a strong presence in the market through continuous R&D investments.

The global ablation market, including PFA, is experiencing significant growth due to technological advancements and increased demand for minimally invasive procedures. The market is projected to grow at a Compound Annual Growth Rate (CAGR) of 8.8% from 2025 to 2032.

While these companies face challenges such as high initial investment costs and regulatory hurdles, the market is driven by the rising prevalence of cardiac arrhythmias and advancements in technology. Growth is expected to be strong in North America and Europe initially, with significant expansion anticipated in the Asia-Pacific region due to improving healthcare infrastructure.

Abbott, in particular, is making strides in the PFA market. The company has received the CE mark for its Volt pulsed field ablation system, allowing it to start commercial cases in the European Union. Abbott also finished enrolling patients in a U.S. Volt study four months early and anticipates Food and Drug Administration approval for Volt in 2026.

Analyst Joanne Wuensch of Citi Research expects Abbott to regain market share with the Volt launch, as its rivals introduced their PFA systems over the past year. The Volt system provides clearer visualization of catheter-tissue contact due to a single-catheter approach.

However, Johnson & Johnson temporarily paused the rollout of its Varipulse PFA device due to reports of neurovascular events. After determining the devices worked as intended, cases have since resumed.

As the market shifts towards PFA for heart rhythm disorders, Abbott is working to catch up with Boston Scientific, Medtronic, and Johnson & Johnson in the electrophysiology market. The competitive landscape for PFA systems remains dynamic, with ongoing innovation, strategic partnerships, and market expansion shaping the future of this promising technology.

The FDA has yet to approve Abbott's Volt pulsed field ablation system, but the company has received the CE mark for it, enabling commercial cases in the European Union.
Analyst Joanne Wuensch of Citi Research anticipates Abbott to regain market share with the Volt launch, given its clearer visualization of catheter-tissue contact due to a single-catheter approach.
Boston Scientific has seen success with its Farapulse PFA device, boosting its electrophysiology sales in 2024, a testament to their ongoing research and development (R&D) efforts.
Medtronic is one of the key players focusing on next-generation Radio Frequency (RF) ablation systems for cardiovascular applications, with involvement in PFA being part of broader efforts to improve electrophysiology treatments.
In the medtech industry, companies like Abbott, Boston Scientific, Medtronic, and Johnson & Johnson are driving advancements in Pulsed Field Ablation (PFA) systems for the treatment of Atrial Fibrillation (AFib).
With the global ablation market, including PFA, experiencing significant growth, companies are anticipating strong growth, particularly in North America and Europe, due to the rising prevalence of cardiac arrhythmias and advancements in technology.
Healthcare news outlets have reported that Johnson & Johnson temporarily paused the rollout of its Varipulse PFA device due to neurovascular events. After determining that the devices functioned as intended, cases have since resumed.