J&J Joins Medtronic & Boston Sci in PFA Race with FDA Approval of VaripulseJ&J Joins Medtronic & Boston Sci in PFA Race with FDA Approval of Varipulse
The competition in the pulsed-field ablation market is intense but is it oversaturated?
November 7, 2024
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At a Glance
- J&J's Varipulse platform receives FDA approval for treating drug-refractory paroxysmal atrial fibrillation.
- The approval is backed by the admIRE study.
- Varipulse competes alongside Medtronic’s and Boston Scientific’s offerings.
It was only a matter of time before Johnson & Johnson MedTech joined Medtronic and Boston Scientific to win approval for pulsed-field ablation technology.
The New Brunswick, NJ-based company said on Thursday that it won FDA approval for the Varipulse platform for the treatment of drug refractory paroxysmal atrial fibrillation (AFib).
FDA approval of Varipulse was supported by data from the admIRE study, a prospective, multi-center, non-randomized trial. Twelve-month outcome data from the pivotal phase of the admIRE study were published in Circulation.
Among 291 patients across 30 healthcare centers in the U.S., 100% achieved acute procedural success, including 98% with first-pass isolation recorded per vein.2 85% achieved peak primary effectiveness when 73-96 applications were applied per vein (n=85), showed minimal adverse events (2.9%), and 25% of procedures were performed without fluoroscopy, likely attributable to integration with the Carto 3 System.
Tim Schmid, executive VP and worldwide Chairman of J&J MedTech, spoke about the competitive landscape in the PFA market during an October call with analysts and investors.
“As it relates to the U.S., you're right, we're seeing continued competition, especially in the ablation space, given that we don't currently have a PFA product, Schmid said in a call last month according to a Seeking Alpha transcript. “But having spent a lot of time in EP labs over the last couple of weeks, I can tell you that we are incredibly excited for the availability of Varipulse.”

Courtesy of Johnson & Johnson: The Varipulse has variable catheter loop size (25mm-35mm) to adjust to the patient’s anatomy.
This is an incredible moment for the PFA market. Dublin-based Medtronic was the first company to kick off the PFA revolution, winning FDA approval for the PulseSelect system late last year. Boston Scientific followed suit garnering approval for the Farapulse system in January.
In a research note earlier this year, Marie Thibault, an analyst with BTIG wrote about a competitive scenario in the PFA market. She noted that despite the number of players the space wasn’t crowded.
“In the third year following the first PFA launches, traditional ablation is expected to be used in roughly half of the ablation cases (42% RF, 10% cryo), while PFA takes the other half (16% Farapulse, 13% Varipulse, 10% PulseSelect, and 7% Sphere-9.),” Thibault wrote. “This matches what we have heard in diligence over the past four years, including an expectation that PFA will quickly become standard of care and that there will be more than one winner in PFA.”
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