Dive Brief:

• Johnson & Johnson published data on Friday showing that 75% of patients were free from atrial arrhythmia recurrence one year after being treated with its Varipulse pulsed field ablation (PFA) device in a pivotal U.S. study.
• The atrial fibrillation (AFib) data, which J&J used to file for approval in the U.S., are consistent with the findings of a European trial that reported results in February. Collectively, the data suggest the Varipulse PFA device is as effective as traditional thermal energy systems and may cut procedure times.
• BTIG analysts wrote in a Sunday note to investors that they believe the results will be sufficient to support Food and Drug Administration approval. The analysts see factors such as mapping integration and cost shaping whether physicians use J&J’s device or Boston Scientific’s and Medtronic’s rival products.

Dive Insight:

J&J reported pilot results from the pivotal U.S. trial alongside final data from the European study in February. At that time, the company had 12 months of follow-up on 20 patients in the U.S. study. Eighty percent of those patients were free from atrial arrhythmia recurrence at one year.

On Friday, J&J presented 12-month data on all 277 study participants at the Heart Rhythm Society (HRS) annual meeting in Boston. The results were similar to the European data. The 12-month success rate was 74.6%, versus 75.6% in the European trial, J.P. Morgan analysts said in a note to investors. The overall primary adverse event rate was roughly 3%, and J&J received no reports of device or procedure-related death.

The proportion of patients free from atrial arrhythmia recurrence at one year was higher in the J&J trial than in pivotal studies of rival devices. Boston Scientific said around 73% of patients met its 12-month efficacy endpoint. The success rate in the paroxysmal AFib cohort of Medtronic’s trial was just over 66%.

However, BTIG analysts said it is misleading to compare data because of differences between the trials.

“We think the bigger takeaway is that all four PFA platforms ... show excellent safety and efficacy profiles that are comparable to traditional thermal energy systems, and enable faster procedure times that we anticipate will become even quicker in real-world use as operators gain more experience,” wrote the analysts.

BTIG expects investor focus to shift to market share dynamics in 2025, when J&J’s Varipulse and Medtronic’s Sphere-9 could be available commercially in the U.S.

Medtronic shared Sphere-9 data at HRS, showing non-inferiority to radiofrequency in a randomized trial. Varipulse and Sphere-9 are under review at the FDA. Boston Scientific’s Farapulse and Medtronic’s Pulseselect are already on the market. 

When deciding which device to use, the analysts said physicians may be more influenced by “patient arrhythmia characteristics, catheter design, anesthesia protocol, mapping integration and cost” than by cross-trial data comparisons.

The anticipated rapid, PFA-driven growth of the electrophysiology market may be more important than market share dynamics, added the analysts. Mapping integration is central to J&J’s pitch for the PFA market. Varipulse is integrated with J&J’s Carto 3D mapping system. Neither Boston Scientific’s Farapulse nor Medtronic’s Pulseselect have integrated mapping.

Tim Schmid, J&J’s worldwide chairman of medtech, said at an investor event in May that 75% of U.S. PFA cases use Carto mapping.