Boston Scientific lifts sales outlook, notes key approval of AFib device with Minnesota ties

Strong sales of a medical device to treat atrial fibrillation helped lift Boston Scientific’s top line last quarter, but an unexpected pause in an important clinical trial to expand the use of the same line of products sent company stock down for the day Wednesday.

Boston Scientific, with approximately 9,400 employees in Minnesota, reported an adjusted net profit of $939 million on $4.2 billion in sales in the third quarter. That amounted to 63 cents of earnings per share on an adjusted basis, surpassing Wall Street expectations by 4 cents per share. The company’s cardiology, peripheral interventions and electrophysiology businesses are based in the state.

Last week, Boston Scientific announced the U.S. Food and Drug Administration approved its Farawave Nav Ablation Catheter, which allows a surgeon to both map the heart and treat paroxysmal atrial fibrillation through the same catheter. Previously, physicians typically used a separate mapping catheter to examine the heart’s electrical patterns before treatment, the company said. In cardiac procedures, catheters are thin tube-shaped devices that can be advanced to the heart through blood vessels, allowing physicians to access the heart without open surgery.

Atrial fibrillation, or AFib, happens when the heart’s chambers quiver or beat out of sync, creating the risk of strokes and heart failure. With paroxysmal AFib, the quivering sensations come and go without warning.

The Farawave device builds on the company’s Farapulse Pulsed Field Ablation System, which includes hardware built in Minnesota. The system treats paroxysmal atrial fibrillation with electrical pulses instead of heat, which can damage heart tissue. Chief Executive Michael Mahoney said the company expects surgeons may use the Farapulse system in more than 60% of global procedures treating the irregular heart rhythm by 2026.

“Doctors are moving surprisingly quickly toward Farapulse,” Mahoney said on a call with investors.

Vijay Kumar, an analyst at Evercore, said in an interview that Farapulse is likely Boston Scientific’s most important product from Wall Street’s perspective. The pulsed field ablation system products drove more than half of the company’s organic growth of 18.5% in the third quarter.

Boston Scientific’s stock price dropped several percent following the earnings announcement Wednesday morning, despite the company’s expectations-beating financial results. The stock closed down by 0.64%, at $87.45. Analysts attributed the drop to a pause in a clinical trial evaluating Farapulse as a first-line treatment for persistent AFib.

The trial is examining the use of Farapulse in patients who did not use anti-arrhythmic drug therapy, which is commonly prescribed for patients living with persistent AFiB, the company said. Dr. Kenneth Stein, the chief medical officer at Boston Scientific, said the company paused the trial “due to a few unanticipated observations in the trial” that are not life-threatening.

“And this in no way at all affects our confidence in the overall performance of the Farapulse system as it’s being used today commercially or in other clinical trials,” Stein said on the call.

In a note to investors, J.P. Morgan analyst Robbie Marcus said the pause is “a non-issue and we’d be buyers on any weakness.” He expects the company to resume enrollment in the trial in about 30 days.

“When they spoke about it on the call,” Kumar said, “I think the first reaction of the market was, ‘Look, if a key growth driver, if they are having some questions, then this might change the narrative for the story next year.’” But Kumar said the issue may be trivial, causing a delay of a few weeks or a month.

Farapulse is part of the company’s electrophysiology division, where sales grew 177% on an organic basis for the quarter, Mahoney said.

The company said its cardiovascular division’s revenue grew by 24.6% on an organic basis compared to the year-ago quarter. The company’s sales of the Watchman, a cardiac device for stroke reduction partly made in Minnesota, grew 18%, Mahoney said.

“Globally, we surpassed 500,000 patients treated with a Watchman device driven by our innovation, clinical evidence and patient-awareness efforts,” Mahoney said.

Boston Scientific’s business grew more in the United States than any other region. In the quarter, the company closed on its $1.16 billion acquisition of Silk Road Medical, a Plymouth-based company that commercializes products preventing stroke in patients with carotid artery disease.

Last week, Abbott Laboratories, which also has a large Minnesota presence and makes medical devices, reported revenue growth and raised its profit guidance. Medtronic reports its latest results next month.

Boston Scientific lifted its full-year sales-growth outlook to approximately 15% on an organic basis, from a range of 13% to 14%.

“In 2025, we will aim to outperform our markets, deliver meaningful margin improvements and grow adjusted earnings per share double digits and faster than sales towards our goal of being the highest performing large-cap med-tech company,” Chief Financial Officer Daniel Brennan said.