Boston Scientific gets FDA approval for heart device, forecasts strong annual profit
By Christy Santhosh and Sneha S K
(Reuters) - Boston Scientific forecast a full-year profit on Wednesday that was largely ahead of analysts' estimates and said the U.S. health regulator has approved its heart device, sending the company's shares up nearly 3%.
The company's Farapulse device is the second pulsed field ablation (PFA) system to get the U.S. Food and Drug Administration's approval, following Medtronic's PulseSelect.
"The approval shortens Medtronic's timing advantage to just one month, down from the three to six months lead we thought MDT's PulseSelect might have," Mizuho analyst Anthony Petrone said.
PFA uses small burns or freezes to cause some scarring inside the heart to help break up the electrical signals that cause irregular heartbeats.
"We expect Farapulse (impact) to be somewhat in the first quarter and much more significant as the year goes on," Boston Scientific CEO Michael Mahoney said, adding that the device is expected to get approval in China and Japan in the second half of the year.
Expectations around performance of medical device makers have increased over the past month after health insurers flagged higher medical costs as people, especially older adults, undergo medical procedures that were delayed during the pandemic.
Fourth-quarter sales at Boston Scientific's cardiovascular unit, which makes devices such as pacemakers and stents, jumped 13.9% to $2.29 billion on a reported basis.
The company forecast 2024 adjusted earnings per share between $2.23 and $2.27, with the midpoint above analysts' estimates of $2.24, according to LSEG data.
On an adjusted basis, Boston Scientific earned 55 cents per share in the fourth quarter, compared with estimates of 51 cents.
(Reporting by Christy Santhosh and Sneha S K in Bengaluru; Editing by Shounak Dasgupta)
