Boston Scientific CEO Mike Mahoney on Wednesday said the Farapulse pulsed field ablation system (PFA) drove increased procedure volumes in the company’s electrophysiology business, where sales climbed 177% in the third quarter from a year ago.
The new cardiac ablation technique is used to treat atrial fibrillation (AFib), a common form of irregular heart rhythm. Due to the rapid adoption of PFA, Mahoney said Boston Scientific now expects PFA to “likely exceed” the company’s previous expectation for the procedure to comprise 40% to 60% of all AFib ablations globally by 2026.
More than 125,000 people have been treated with Farapulse, which has shown “excellent outcomes as well as efficiencies,” Mahoney said on the quarterly call. The company recently received approvals for the device in Japan and China, and won Food and Drug Administration approval for the Farawave Nav catheter combined with software that enables mapping with the procedure.
Boston Scientific is now evaluating Farapulse for the treatment of drug-refractory, persistent AFib and plans to submit the results of that trial to the FDA later in the fourth quarter, Mahoney said. The company aims to gain a label expansion for the indication in the second half of 2025, the CEO said.
Mahoney said the company is also studying the device in drug-naive, persistent AFib patients but has temporarily paused that trial to assess some unanticipated observations. “It is our intention to resume enrollments in the near term,” Mahoney said.
Citi Research analyst Joanne Wuensch, in a note to clients after the call, said the pause in the study was weighing on the company’s shares despite the commentary that the trial would restart shortly.
Boston Scientific’s stock fell about 5% to $83.65 in morning trading on the New York Stock Exchange.
Boston Scientific executives also provided an update on acquisition activity, saying the company expects to close on the $3.7 billion purchase of Axonics, a maker of devices to treat urinary and bowel dysfunction, in the fourth quarter. The company delayed the expected closure date for the purchase to the second half of 2024 after the Federal Trade Commission asked for additional information on the deal for a second time.
During the third quarter, Boston Scientific completed the $1.26 billion acquisition of Silk Road Medical, a maker of stroke prevention devices. The company remains focused on deal-making. “Our top capital allocation priority remains strategic, tuck-in M&A,” said CFO Dan Brennan.
The company also announced an executive move on the call. Eric Thépaut, president of the Europe, Middle East and Africa region, will retire in December. He will be replaced in the role by Xavier Bertrand, currently vice president of peripheral interventions in EMEA.
