Boston Scientific is keeping the ball rolling in pulsed field ablation, posting 177% electrophysiology growth in the third quarter powered by the launch of its Farapulse system for atrial fibrillation earlier this year.
That trajectory follows up on sales gains of 70% and 125% in the sector during the first and second quarters, respectively, compared to the same periods the year before.
“We have now treated over 125,000 patients with Farapulse, driving rapid and transformative conversion from RF and cryo to PFA,” CEO Mike Mahoney said on the company’s earning call, speaking of the switch from traditional thermal ablation procedures. “As a result of this accelerated conversion, we now expect PFA to likely exceed our previously communicated range of 40% to 60% of global afib ablations by 2026.”
Boston Scientific also obtained regulatory approvals for Farapulse in Japan and China earlier this year, and Mahoney said he expects to see contributions there start in 2025. And this past week, the company received an FDA approval for the upgraded Farapulse Nav catheter, which incorporates magnetic navigation and connects with heart mapping and visualization software.
Farapulse’s approach, currently greenlit in the U.S. for intermittent afib, is also being studied in persistent disease that has not responded to drug therapies; Mahoney said the company plans to submit that clinical data to the FDA for review by the end of this year, and is eyeing a label expansion in the second half of 2025.
And late last year, Boston Scientific launched a trial to explore pulsed field ablation as a first-line therapy, in a new potential category of patients that have not received any anti-arrhythmic drugs—however, that study, known as AVANT GUARD, has been delayed.
“As we have neared the end of this enrollment, we have elected to temporarily pause the trial to assess a few unanticipated observations,” Mahoney said. “It is our intention to resume enrollment in the near term.”
Boston Scientific’s global chief medical officer, Kenneth Stein, said on the investor call that the observations were not life-threatening, but that he was not able to provide more details on the ongoing study.
“I just want to emphasize that the patient population we're studying in AVANT GUARD—which is drug-naive, persistent AF patients—has not previously been studied,” said Stein. “It is a population that's not indicated for ablation today under guidelines, and it's not the population that's being treated today with the Farapulse system.”
The company’s stock price fell about 4%, to about $83.70, following the news of the study delay.
Meanwhile, the company as a whole posted third quarter net sales of $4.209 billion, for a gain of 19.4%—well outpacing its previous forecasts of 13% to 15% growth for the three-month period.
That covers a 25.0% increase across the company’s cardiology and peripheral vascular divisions, which amounted to $2.731 billion, as well as 10.3% growth among medical surgical tools—including endoscopy, urology and neuromodulation—that totaled $1.479 billion.
As a result, the company bumped up its financial forecasts for the full year, saying it now expects to see 16.5% growth versus the previous range of 13.5% to 14.5%.
Boston Scientific was also able to close its $1.26 billion deal for Silk Road Medical and its carotid artery vascularization procedure, but it is still waiting to finalize its acquisition of Axonics.
The company said it still expects its $3.7 billion offer for the incontinence neuromodulation devicemaker to go through by the end of this year; the deal’s timeline was pushed back after the FTC asked for more information during its review back in April.