Shares of BSX were up more than 2% at $62.79 in morning trading on the back of the news, as the company also posted strong fourth-quarter earnings results. MassDevice‘s MedTech 100 Index was up nearly 1%.
The much-anticipated approval makes Boston Scientific the second company to earn an FDA nod for PFA that treats AFib. Approval enables the use of Farapulse in the isolation of pulmonary veins to treat drug-refractory, recurrent, symptomatic, paroxysmal AFib.
“The approval of the Farapulse PFA system marks an important milestone for the millions of people living with paroxysmal AF and is an incredible opportunity to bring the first PFA system designed and built solely for this type of ablation therapy to physicians in the U.S.,” said Nick Spadea-Anello, president, Electrophysiology, Boston Scientific. “A high bar has been set by performance of the system in clinical and commercial settings – where more than 40,000 patients have been treated to date – and we look forward to continuing to lead the way with this differentiated technology in the growing PFA space.”
More about the Boston Scientific Farapulse system
Farapulse is already a known commodity in the competitive PFA space. The nonthermal treatment uses electric fields to selectively ablate heart tissue. Boston Scientific bought Farapulse for nearly $300 million in 2021. The company shared its high hopes for the technology at its Investor Day event earlier this year, with analysts projecting FDA approval and rapid adoption in the near future.
Farapulse delivers pulsed field energy with the Farawave ablation catheter, Farastar ablation generator and Faradrive steerable sheath. Boston Scientific’s VersaCross Connect access solution complements the sheath to provide safe and effective left heart access.
The Farawave catheter treats a range of pulmonary vein anatomies using an over-the-wire catheter with a variable basket and flower shapes. This allows for the device to adapt to individual patient anatomies.
Boston Scientific also has a new trial underway to look at Farapulse as a first-line persistent AFib treatment. Outcomes will be compared to outcomes following use of anti-arrhythmic drug (AAD) therapy, a common treatment for persistent AFib.
The company also has its fourth-quarter results
Boston Scientific posted fourth-quarter results that came in ahead of the consensus forecast.
The Marlborough, Massachusetts-based company posted profits of $504 million, equalling 34¢ per share. Boston Scientific recorded sales of $3.7 billion for the three months ended Dec. 31, 2023. It reported a more than tripled bottom line on sales growth of nearly 15%.
Adjusted to exclude one-time items, earnings per share totaled 55¢. That landed 4¢ ahead of expectations on Wall Street. Sales also topped forecasts as analysts projected sales of $3.6 billion.
Boston Scientific recorded double-digit revenue growth in both the MedSurg (11.1%) and Cardiovascular (13.9%) segments.
“I am grateful to our global team, and proud of our exceptional results in 2023,” said Mike Mahoney, chair and CEO, Boston Scientific. “We are excited about our future and long-range plans as we deliver on our mission to transform patient lives.”
Boston Scientific expects adjusted EPS for 2024 to range between $2.23 and $2.27. It projects year-over-year sales growth between 8.5% and 9.5%.
The analysts’ view
BTIG analysts Marie Thibault and Sam Eiber called Farapulse’s approval “the cherry on top” of a “stellar finish” to 2024. They noted an immediate U.S. launch and expect buzz around the system at the AF Symposium, which starts tomorrow. Additionally, they expect rapid adoption of the system.
The analysts did note a “blemish” on the company’s earnings call, which surrounds its TAVR technology. Boston Scientific extended timelines for the Acurate Prime TAVR system, but the analysts found a silver lining in Acurate neo2’s continued share victory in Europe.
Thibault and Eiber reiterated their “Buy” rating for Boston Scientific.