Boston Scientific's Farapulse pulsed field ablation system secures FDA approval in afib

Boston Scientific had a lot to celebrate this morning, as the announcement of an FDA green light for its pulsed field ablation system coincided with the company’s fourth-quarter earnings release, which posted strong sales growth across the board.

The agency’s approval of the Farapulse procedure for symptomatic and drug-resistant atrial fibrillation adds a new option to Boston Scientific’s catalog of radiofrequency-powered and cryoablation catheters—and puts the company in closer competition with Medtronic in an underpenetrated market, following an FDA nod for the latter’s PulseSelect system last December.

Pulsed field ablation uses tuned bursts of electrical energy to disrupt some types of cells more than others without excess heat, allowing it to target the cells responsible for triggering irregular heartbeats while sparing other sensitive nerves and tissues from the unwanted side effects that can come with thermal ablation.

“We are thrilled to enter the U.S. market immediately,” Boston Scientific CEO Mike Mahoney said on the company’s earnings call. 

“We continue to invest in clinical evidence to study new indications and support access to our Farapulse technology,” Mahoney added. “We're excited to bring this innovative technology to more markets and expect approval of Farapulse in China and Japan in the second half of this year.”

While the FDA’s approval covered intermittent afib, the company has also been studying Farapulse’s use as a first-line treatment for persistent afib, as well as developing a navigation-enabled version that connects to the Faraview software module and is aiming for a new regulatory green light by the end of the year. Medtronic’s PulseSelect, meanwhile, received a go-ahead for both intermittent and persistent afib. 

Farapulse previously received a CE mark approval in Europe in early 2021, a few months before Boston Scientific acquired the system and its eponymous developer through a $295 million deal. 

Since then, Mahoney said the next-generation approach has been used to treat more than 40,000 patients worldwide—and, in the fourth quarter of 2023, helped to boost Boston Scientific’s global electrophysiology revenues by 46%.

Company-wide, net sales for the quarter were up 14.9%, with the $3.73 billion haul outpacing previous financial guidance that had predicted between 9% and 11% growth. For the full year, net sales of $14.24 billion equated to a 12.3% gain over 2022.

“Our global performance represented one of the strongest years in the company’s history, exceeding our financial goals that we set for the year,” Mahoney said. 

Broken down by segment, the company’s cardiovascular division reported 13.9% growth for the quarter and 12.6% for the year, with sales totals of $2.29 billion and $8.82 billion, respectively. 

That included double-digit gains in structural heart valve sales, powered by expansions of the Acurate Neo2 transcatheter aortic implant in Europe, while the launch of the Watchman FLX Pro implant for left-atrial appendage closure in the U.S. brought 23% domestic quarterly growth.

However, Boston Scientific’s bid to bring the Acurate Prime, a larger version of the Acurate Neo2 TAVR system, to U.S. shores may see a delay: Following a planned interim analysis of U.S. trial data, the company will now wait to analyze the full one-year follow-up data gathered from a randomized cohort of 1,500 patients before it finalizes its regulatory submission strategy, Mahoney said, with the readout expected to come toward the end of this year. 

“Therefore, we no longer anticipate the approval of Acurate Prime in the U.S. in 2024. Additionally, in alignment with the FDA, we are suspending enrollment in the single-arm continued access study, while continuing to enroll in the randomized, extended-durability cohort. We expect to have more information in the second half of 2024, following the full data review,” he said, adding that the company is “on track” to secure a CE mark for Acurate Prime in 2025.

Meanwhile, the medical-surgical unit—spanning endoscopy, urology and neuromodulation—logged an 11.1% gain for the quarter and 10.4% for the full year, amounting to $1.44 billion and $5.42 billion. 

Boston Scientific expects to see another boost in that area after it closes its tuck-in acquisition of Axonics, the maker of neurostimulation implants for urinary and fecal incontinence, through a $3.7 billion deal that was announced earlier this month at the J.P. Morgan Healthcare Conference.

Axonics will support the company’s entry into the space with both rechargeable and recharge-free sacral implants, boasting battery lives rated from at least 10 to more than 20 years. Axonics previously received agency approval for its fourth-generation rechargeable device in January 2023. The deal will also include Bulkamid, an FDA-approved, hydrogel-based urethral bulking injection for female stress urinary incontinence.

Looking ahead to 2024, Boston Scientific estimated net sales growth to land between 8.5% and 9.5% for the year, as well as between 7.5% and 9.5% for the first quarter.