Boston Scientific apparently knows a good bet when it sees one. The company reported that, after receiving an FDA green light in early 2024, its Farapulse pulsed field ablation system raked in more than $1 billion in sales by the end of that calendar year.
That includes treating more than 200,000 patients with the irregular heartbeat known as atrial fibrillation—and the sum more than makes up for the $295 million that Boston Scientific put down to acquire the technology in mid-2021.
The company’s leadership has previously described Farapulse as the most transformational product in Boston Scientific’s history. Since its commercial launch, it has bolstered quarterly electrophysiology sales in an upward trajectory—including by 70% year-over-year in the first quarter of 2024, 125% in the second, and 177% in the third.
In the fourth quarter, EP sales were up 171%, with Farapulse adoption spreading in the U.S., Europe, the Middle East and Africa, as well as through more recent launches in Japan and China. For the full year, the division’s revenues were up 138%.
Alongside other cardiovascular device sales—including in coronary and structural heart therapies, rhythm management, and the company’s Watchman franchise, as well as peripheral vascular interventions—that side of the company collected $10.76 billion for the year and $2.94 billion for the fourth quarter, for gains of 22% and 27%, respectively.
In medical surgical tools, spanning endoscopy, urology and neuromodulation, Boston Scientific recorded $5.99 billion for the year and $1.62 billion for the quarter, both up about 7% compared to their previous periods.
That brought the company’s total hauls to $16.75 billion and $4.56 billion—with annual growth of 16% clocking in just above its previous estimate of about 15%.
At last fall’s TCT Conference, CMO Ken Stein told Fierce Medtech in an interview that Farapulse has been one of the most successful new cardiovascular product launches in the past decade. The company has also seen many patients undergo concomitant procedures with its Watchman implant for sealing the left atrial appendage. Both interventions aim to counter the long-term risk of stroke that comes with afib.
Farapulse’s FDA approval currently covers its use in intermittent, or paroxysmal afib; for persistent afib, the company recently put forward data from a clinical trial of drug-resistant, symptomatic cases that met its primary safety and efficacy endpoints by lowering the signs of arrhythmia over one year.
Boston Scientific has also been studying Farapulse as a first-line therapy, given ahead of medications. That trial, known as AVANT GUARD, was paused late last year before resuming in November, over what the company described as “unanticipated observations.” In his interview, Stein said they could not provide additional details without jeopardizing the blinding of the study.
Meanwhile, Farapulse may also continue to make headway in the commercial market, while Johnson & Johnson paused the U.S. rollout last month of its competing pulsed field ablation system, Varipulse, following four reports of strokes among treated patients. However, Medtronic has spent the last year collecting FDA approvals for two separate platforms, the latest being Affera with its spherical catheter and integrated cardiac navigation.
Looking ahead to the rest of 2025, Boston Scientific has plotted about 12.5% to 14.5% growth for the full year, and 17% to 19% for the first quarter.
Last fall also saw the company close its billion-dollar acquisitions of Silk Road Medical and Axonics. It is currently waiting to finalize its purchases of Intera Oncology and Bolt Medical.