Abbott joins AFib-treating race with tech that may skip general anesthesia

With a key regulatory approval secured in Europe, Abbott Laboratories is joining the race to commercialize technology that offers a new way to treat a common heart arrhythmia causing strokes.

The pulse field ablation (PFA) technology from Abbott, a medical device maker with roughly 5,000 workers in Minnesota, may remove a roadblock to care by reducing the need for general anesthesia often required for procedures treating atrial fibrillation with electric energy, said Dr. Christopher Piorkowski, the company’s chief medical officer of electrophysiology.

Atrial fibrillation is a quivering heart condition affecting more than 35 million people worldwide, and can lead to deadly or disabling strokes if left untreated, as blood pools in the heart and can form clots that may travel to the brain. Ablation procedures treat AFib by severing electrical connections on the heart that cause the erratic heartbeats.

Medtech CEOs have said PFA is a transformational treatment for the medtech industry. Analysts have estimated the market is worth billions of dollars worldwide.

Abbott’s Volt system stands out from competitors’ devices — which received earlier approvals — with its catheter topped with a balloon that expands inside what looks like a tiny basket. Piorkowski said the device’s balloon makes its electric field more predictable and minimizes the amount of electric energy that churns into the heart’s blood.

“It makes the procedures faster,” Piorkowski said of Abbott’s PFA. “It standardizes the procedure in terms of safety and efficacy, and it makes these procedures simpler and safer.”

Physicians have long used ablation technology to treat AFib with extreme heating or cooling instead of electricity, but doctors say PFA is quicker and safer.

The company did not say when it might secure approval in the United States, but analysts estimate sometime in 2026.

The European CE Mark approval last week allows the Illinois-based company to start commercializing PFA there after competitors Medtronic, Boston Scientific and Johnson & Johnson MedTech attained CE Mark in 2023 and 2024.

During a call with investors in October, Abbott CEO Robert Ford acknowledged the company’s division housing PFA systems was growing slower than competitors, whose devices were already launching in the United States. In January, he said the electrophysiology segment would be even more competitive in 2025, but added that the company’s “pipeline is very strong.”

BTIG analyst Marie Thibault said she previously expected Abbott’s electrophysiology division to slow down, but the opposite occurred, as strength in its heart-mapping technology doctors use in tandem with other companies’ PFA devices boosted it. The expedited timeline is a “clear positive,” she said.

“Abbott’s electrophysiology segment has held up a lot better than I think some of us onlookers had expected originally,” Thibault said.

Piorkowski said Abbott has worked on PFA technology for more than 10 years, and previously tested a lasso-shaped device in 2020.

“However, we felt that this design that we had in our hands at that time was not meeting our expectations in terms of efficacy, safety and workflow,” he said.

The company started from scratch designing the Volt system, Piorkowski said, focusing on the recipe of the high-voltage and short duration electric pulses it delivers. It developed new methods to test the biological effect of the device’s waveform, which can lead to muscle contractions if shifted slightly.

Muscle contractions may occur with PFA systems when electric stimuli activate muscles around the heart while a patient is not relaxed by general anesthesia, Piorkowski said.

“Sometimes, the patients really jump like 10 centimeters on the EP table,” he said, referring to electrophysiology. “And that is really unwanted because it’s creating patient discomfort, and even more importantly, it jeopardizes the stability of the ablation catheter.”

While general anesthesia is the standard of care in the United States, physicians elsewhere might not have an additional anesthesiologist present, Piorkowski said. The Volt system was designed in part to reduce muscle contractions without requiring heavy sedation. With the Volt system, doctors could administer light sedation instead, Piorkowski said.

In the European trial, around 40% of patients were treated without general anesthesia, Piorkowski said, giving the company confidence the waveform is working. Abbott will design deliberate studies randomizing patients between general anesthesia and nongeneral anesthesia groups to demonstrate efficacy going forward, he added.

Piorkowski said Abbott finished enrollment for a trial in the United States in September, which is a key step in FDA approval. He said it’s difficult to give an accurate timeline for when the company might receive Food and Drug Administration approval. He said roughly 600 patients worldwide have been treated with Volt.

Thibault estimated Volt’s FDA approval in 2026. Morningstar Analyst Debbie Wang said Abbott will still face a challenge in establishing a footprint in the United States with its PFA systems.

“Abbott has largely been behind the eight ball compared to Boston Scientific and Medtronic on the PFA,” Wang said. “So, I think it’s great that it’s gotten the CE Mark a little bit earlier than I expected. However, the big prize for ablation is really the U.S.”

Piorkowski said the company received European approval quicker than expected due to faster-than-expected trial enrollment and by shifting the time that regulators initially assess the safety and efficacy of the device from 12 months to six months.

“This was a very scientific and academic discussion we had with the regulators,” he said. “They followed our argumentation, and that helped us to gain CE mark with six-month follow-up data out of the clinical trial, but of course we are following these patients even longer for 12 months.”