- More than 75% of clinical trial participants were free from atrial arrhythmia recurrence one year after being treated with Johnson & Johnson’s Varipulse pulsed field ablation (PFA) device, the company said Friday at the AF Symposium in Boston.
- The figure, which is up on the almost 71% seen at an interim analysis, compares favorably to data on PFA devices from Boston Scientific and Medtronic, although BTIG analysts noted that J&J enrolled younger patients.
- Even so, the analysts called the results “impressive” in a note to investors. The data come from a trial of patients in Canada and Europe, but an interim look at a U.S. study shows the performance is currently consistent across geographies.
J&J subsidiary Biosense Webster is working to become the third company, after Medtronic and Boston Scientific, to bring a PFA device to the U.S. market. The investigational device, Varipulse, features a catheter, PFA generator and integration with J&J’s Carto 3D mapping system. The need for PFA mapping has been a subject of debate, but latecomers Abbott and J&J are pitching their integrations as positives.
J&J put its device to the test in the Inspire study, a clinical trial that enrolled 272 people with paroxysmal atrial fibrillation (AFib) at sites in Canada and Europe. After 12 months, just over 75% of subjects were free from atrial arrhythmia recurrence. The figure rose to 80% in patients who received a level of PFA application that J&J called “optimal.” BTIG noted the optimal level of PFA applications was at least 48.
The proportion of patients free from atrial arrhythmia recurrence after 12 months was higher than in the pivotal studies of rival devices. Around 73% of patients in Boston Scientific’s PFA trial met the 12-month efficacy endpoint. The figure in the paroxysmal AFib cohort of Medtronic’s trial was just over 66%.
However, cross-trial comparisons can be misleading because differences between the studies, as well as differences between the interventions, influence the results. BTIG analysts noted that participants in the J&J trial were younger and had a slightly lower risk of stroke. The average age in the J&J trial was around 59 years, compared with over 62 and 63 years, respectively, in the Boston Scientific and Medtronic studies.
J&J presented final data from Inspire alongside interim results from the pilot phase of the Admire study it is running in the U.S. Eighty percent of the 20 patients with 12 months of follow up were free from atrial arrhythmia. BTIG analysts told investors they “view these results as favorable, but with just a few patients evaluated, we await results from the pivotal phase, which enrolled up to 408 patients, in the near future.”
The U.S. data could position J&J to start competing for the PFA portion of an AFib market that RBC Capital Markets analysts predict will grow to $5.8 billion by 2026. The RBC analysts expect “a rapid shift to PFA,” although their counterparts at BTIG noted concerns including the price of pulsed field ablation that could slow the transition. Physicians said PFA costs twice as much as radiofrequency ablation in Europe.
“With [electrophysiology] typically a profit center for hospitals and hospital margins under pressure, this is a concern,” the analysts wrote. “These doctors expect pricing to decrease as PFA volume increases. Combining ablation and mapping in one catheter may also be preferred, since that is one less catheter to pay for.”