Abbott has begun clinical development of a pulsed field ablation (PFA) device that could rival Boston Scientific, Johnson & Johnson, and Medtronic for an emerging atrial fibrillation (AFib) market.
Traditionally, physicians have used heat or cold to destroy the cells that cause abnormal heart rhythms in people with AFib. PFA is an alternative way to destroy the cells. Rather than heat or freeze troublesome cells, PFA devices deliver high-energy electrical pulses to ablate the target tissue. Interest in the approach is underpinned by evidence that PFA may reduce the risk of damage to adjacent healthy tissue.
Abbott recently began studying its PFA device candidate, Volt, in Australia, where physicians have treated more than 30 people. The company said in its statement that it is planning procedures across Asia Pacific and Europe, and aiming to receive approval to run a study in the U.S. in the first half of 2024.
Volt is entering a competitive space. Abbott sells catheters that use radiofrequency to heat cells and treat AFib, as well as technology for mapping the heart, but is arriving late to the PFA opportunity. Medtronic won U.S. Food and Drug Administration (FDA) approval for its PFA device last month, and Boston Scientific expects to secure FDA authorization in the first quarter of 2024.
With J&J’s PFA device also on course to come to market before Volt, Abbott looks set to cede a head start to three significant competitors. However, the company believes the first wave of PFA devices have limitations, such as the need for “multiple ablations with the catheter positioned in various locations to effectively treat targeted tissue,” that mean Volt can make an impact despite being fourth to market.
Volt combines a balloon-in-basket catheter with Abbott's heart-mapping system, EnSite X EP. Abbott says the design “can result in more accurate ablation procedures as it provides physicians a clearer indication to make improved contact with the targeted heart tissue due to the catheter's unique positioning, handling and steering.” The balloon feature is designed to improve how the catheter creates lesions.