Abbott snags early CE mark for Volt PFA device

Dive Brief:

• Abbott announced on Thursday that it obtained Europe’s CE mark earlier than expected for its Volt pulsed field ablation system, designed to treat atrial fibrillation. The company has initiated commercial PFA procedures in the European Union.

  
  

• The manufacturer is striving to catch up with Boston Scientific, Medtronic, and Johnson & Johnson, who have already launched PFA devices in an electrophysiology market that is rapidly transitioning to the new cardiac ablation technique for normalizing heartbeats in individuals with heart rhythm disorders.

  
  

• Abbott stated that its Volt system aims to address what it perceives as the shortcomings of first-generation PFA devices.

  
  

A cardiac monitor displays vital heart rate data and other critical health indicators in a medical setting.

Dive Insight:

Abbott has lagged behind its medtech competitors in launching a PFA device, but now intends to speed up its European rollout in the latter half of this year, starting with EU physicians familiar with the system from the company’s clinical trials.

Boston Scientific reported increasing electrophysiology sales in 2024, driven by the success of its Farapulse PFA device, while Medtronic forecasted robust growth in its cardiac ablation solutions sector. J&J, on the other hand, faced a setback when it halted the rollout of its Varipulse PFA device due to reports of neurovascular events. J&J has since resumed procedures after confirming the devices functioned as intended.

Abbott’s presence in the electrophysiology market has declined as competitors released their PFA systems over the past year, according to Citi Research analyst Joanne Wuensch. However, the company is expected to regain its market position with the Volt launch, Wuensch noted in a Thursday report to clients.

Abbott completed patient enrollment in a U.S. Volt study four months ahead of schedule, and expects to finish 12 months of follow-up later this year. The company has stated it expects Food and Drug Administration approval for Volt in 2026.

PFA uses electrical pulses to eliminate the cells responsible for AFib, potentially offering a safer treatment with reduced risk of damage to surrounding tissue compared to older ablation methods that use heat or cold to correct the heart’s faulty signals. 

Among PFA systems, Abbott asserts that Volt offers clearer visualization of contact between the catheter and targeted tissue due to a single-catheter approach, reducing the number of therapy applications needed and improving patient outcomes.

The company stated it received CE mark approval based on strong clinical trial results showing Volt achieved pulmonary vein isolation, the technique of destroying the tissue causing AFib, in 99.1% of patients’ veins.

In addition to its U.S. Volt trial, Abbott is exploring PFA technology aimed at delivering focused energy to create targeted lesions at precise locations in the heart.