Boston Scientific study meets goals for PFA in persistent AFib

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Dive Brief:

  • A study of Boston Scientific’s Farapulse pulsed field ablation system met safety and efficacy objectives in people with persistent atrial fibrillation (AFib), an irregular heart rhythm that lasts more than seven days, who do not respond well to drug therapy.
  • A significant number of patients in the single-arm trial, called Advantage AF, were able to discontinue drug therapy and saw improvements in their quality of life, Vivek Reddy, the study’s principal investigator and a paid consultant for Boston Scientific, said in a statement. The results were presented last week at the annual AF Symposium in Boston.
  • Data from the trial will be used to support an FDA submission for an expanded indication for Farapulse in persistent AFib, Brad Sutton, Boston Scientific’s chief medical officer for atrial fibrillation solutions, told MedTech Dive. The company expects to receive the label expansion by the end of this year.

Dive Insight:

Farapulse has quickly gained acceptance among physicians since its launch in January 2024, giving a big boost to Boston Scientific’s electrophysiology device sales. Medtronic and Johnson & Johnson also have launched competing PFA systems, though J&J has temporarily paused U.S. cases to assess four neurovascular events.

Farapulse is approved to treat paroxysmal, or intermittent, AFib in patients who do not respond well to antiarrhythmic drugs. The persistent form of the condition represents 25% of all AFib cases, according to Boston Scientific.

The Advantage AF study evaluated Farapulse in 260 patients who were drug intolerant to at least one Class I/III antiarrhythmic medication at 43 U.S. and global sites one year after the procedure. The results met the study’s primary safety endpoint with a 2.3% rate of major events, below the 12% performance goal, with no reports of stroke.

“I was additionally happy that the safety endpoints that we did see were, by and large, completely unrelated to the ablation energy,” Sutton said. “And importantly, in the context of what we’re seeing with competitive technologies, we saw no strokes in this study.”

The primary effectiveness rate was 63.5%, meeting the study’s acceptance criteria of 40%. “We were highly statistically significant in meeting that performance goal with an event-free rate of 63.5%,” said Sutton.

In addition, more than 85% of patients were free from recurrent symptoms during the year. “There was a significant improvement in the quality of life,” Sutton said.

BTIG analyst Marie Thibault noted that about two-thirds of the operators in the study did not have experience with the Farapulse catheter. “We believe these results will support the anticipated label expansion into the persistent AF population later this year,” Thibault wrote in a Jan. 16 report to clients.

Boston Scientific is also studying Farapulse as a first-line treatment in patients with persistent AFib, comparing PFA to anti-arrhythmic drugs, in the Avant Guard trial.