Dive Brief:

• Needham analysts are predicting Boston Scientific will report the success of its Farapulse pulsed field ablation (PFA) device in a pivotal trial later this month.
• Based on the timing of enrollment, the analysts believe the adaptive clinical trial met its primary endpoints, they wrote in a research note on Friday. Positive results could position Boston Scientific to win U.S. approval for Farapulse in the second half of next year and go on to capture a significant slice of the nascent PFA market. 
• The Needham analysts believe Boston Scientific’s randomized, controlled trial could give it an advantage over Johnson & Johnson and Medtronic, both of which ran studies that lacked control arms.

Dive Insight:

PFA, a procedure that uses electrical pulses to treat atrial fibrillation, could disrupt a market worth billions of dollars a year. Needham analysts estimate that the global electrophysiology market was worth $7.6 billion last year and was dominated by J&J and Abbott, which respectively accounted for 48% and 25% of sales. Medtronic and Boston Scientific, which accounted for 17% and 8% of the market respectively last year, could shake up the space with upcoming PFA launches.

Medtronic is on course to become the first company to sell a PFA device in the U.S., but Boston Scientific is following close behind. Boston Scientific is set to share pivotal data at the 2023 European Society of Cardiology later this month, and the Needham analysts believe the study met its primary endpoint.

“Given the timing of enrollment (March 2021 to June 2022), we suspect that enrollment did not reach 750 patients,” the analysts wrote in a note to investors. “Assuming that this is correct and since [Boston Scientific] has not indicated that the trial was stopped for futility, we think it means that the trial probably met its primary endpoints given its adaptive design.”

The primary safety and efficacy endpoints compare outcomes in PFA to standard-of-care radiofrequency ablation and cryoballoon ablation. With neither J&J or Medtronic comparing their devices to standard of care, the analysts said Boston Scientific's “rigorous design provides a marketing advantage,” assuming its study meets the primary endpoints. 

Boston Scientific could have a “very significant advantage” if its study hits secondary endpoints designed to show if Farapulse is superior to standard of care. However, while the analysts believe the study met its primary non-inferiority endpoints, they “do not expect superiority.” 

Success on the primary endpoints could be enough for Boston Scientific to win U.S. Food and Drug Administration approval in the second half of 2024 and add Farapulse to an electrophysiology portfolio that was boosted recently by the authorization of a cryoablation system. Farapulse and the cryoablation device, POLARx, are central to Boston Scientific’s current and future growth.

“Growth in this business has already accelerated as newer products including Farapulse PFA and POLARx CBA have been driving market share gains outside the U.S,” the analysts wrote.