Dive Brief:
- Boston Scientific’s pulsed field ablation catheter, Farapulse, was noninferior to Medtronic’s Arctic Front cryoballoon in a randomized trial, researchers found in a study published in The New England Journal of Medicine.
- The study, which was published Monday and funded by a Swiss hospital, randomized 210 patients with symptomatic paroxysmal atrial fibrillation to undergo PFA or cryoablation. Atrial tachyarrhythmia, a heart rhythm disorder where the atria beat too fast, recurred in 39 patients in the PFA cohort and 53 people in the cryoablation group.
- Medtronic reported declines in its cryoablation business last year but said the losses were offset by growth of its PulseSelect single-shot catheter, which competes with Farapulse for the growing PFA market.
Dive Insight:
Boston Scientific compared PFA with Farapulse to conventional radiofrequency or cryoballoon ablation in its Advent clinical trial from 2021 to 2023. The study found PFA was noninferior to conventional therapy on a composite endpoint that looked at one-year outcomes including atrial tachyarrhythmia after a three-month period.
However, the authors of the new NEJM paper said Advent and other PFA studies “lacked continuous rhythm monitoring, which limited the sensitivity to detect the recurrence of atrial tachyarrhythmia and the burden of atrial fibrillation.” All patients in the Swiss hospital study received Medtronic’s Reveal Linq, an implantable cardiac monitor, for continuous rhythm monitoring.
The researchers began checking for the recurrence of atrial tachyarrhythmia 91 days after ablation with either Farapulse or Arctic Front. Through day 365, the researchers saw recurrences in 37.1% of the PFA patients and 50.7% of the cryoablation patients, achieving the study’s primary noninferiority endpoint.
Once the noninferiority endpoint was met, the researchers checked whether the result showed PFA was statistically superior to cryoablation. The superiority test was “formally positive,” they said. However, because the result “reached only borderline statistical significance,” the researchers concluded larger outcome trials are needed to show whether PFA is superior to cryoablation.
No PFA patients in the Swiss trial had energy-related complications such as pulmonary vein stenosis, persistent phrenic nerve palsy or atrioesophageal fistula. The finding is in line with the results of Boston Scientific’s Advent trial.
The Swiss trial also added to evidence that PFA procedures are faster than traditional ablation methods. PFA procedures averaged less than one hour in the study, which was quicker than cryoblation. Researchers said the duration is less than half the time reported in previous thermal ablation trials.
Sales figures suggest physicians are switching from cryoablation to PFA. Medtronic reported declines in its cryoablation business in the first and second quarters of its 2025 financial year, a period that spanned from late April 2024 to late October 2024.
In August, CEO Geoff Martha said that PFA growth in the first quarter more than offset cryoablation declines and repeated the message on the second-quarter earnings call.
Martha framed the shift as a net positive at the J.P. Morgan Healthcare Conference in January. The CEO said cryoablation is “a nice business but it's fairly niche.” Launching PFA devices had enabled Medtronic to get its products into “big, high-volume centers,” Martha said, leading the CEO to predict “strong growth going forward.”
Meanwhile, Boston Scientific has claimed leadership of the PFA market.
