Trouble in PFA Paradise: Boston Sci Pauses AVANT GUARD TrialTrouble in PFA Paradise: Boston Sci Pauses AVANT GUARD Trial

The study is looking at treating a new patient population of drug-naïve persistent atrial fibrillation patients.

Omar Ford

October 23, 2024

2 Min Read
Farapulse Pulsed-Field Ablation
Image courtesy of Boston Scientific

At a Glance

  • Despite reporting strong earnings and increasing full-year guidance, news of the trial pause led to a 4% drop in stock.
  • The trial was paused due to unanticipated observations during the study.
  • BTIG analysts suggest the trial delay is not alarming, emphasizing that the observations were not life-threatening.

Yes, pulsed-field ablation (PFA) is one of the hottest segments of medtech right now, but that doesn’t mean there won’t be bumps in the road.

Boston Scientific reported such a bump when it announced it was temporarily pausing its AVANT GUARD trial. The study is looking at how the company’s Farapulse PFA could treat a new patient population of drug-naïve persistent atrial fibrillation patients.

Kenneth Stein, Boston Scientific’s Global Chief Medical Officer, commented on the decision to pause the trial, according to a Seeking Alpha transcript of the company’s 3Q earnings call. He noted that this was an entirely new patient population that the Farapulse was treating.

“... Due to a few unanticipated observations in the trial, which is studying a completely new population, which is drug-naive patients with persistent atrial fibrillation, which Farapulse is not currently indicated to treat - we did elect to temporarily pause enrollment until we develop a better understanding of the observations,” Stein said according to a Seeking Alpha transcript of the call. “While none of the observations were life-threatening, we did make a decision to temporarily pause, but it is our intention to resume enrollments in the near term.

Despite having a strong earnings report, news of the temporary pause caused shares of the Marlborough, MA-based company to drop by 4%.

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Marie Thibault, an analyst with BTIG, wrote that the delay does not appear to be significant and is overshadowing a strong earnings report that had Boston Scientific increasing its full-year guidance.

“While we do not think there is cause for alarm since the 'unanticipated observations' are not life-threatening, the hyperfocus on Farapulse means Boston Scientific is trading down despite a stellar report,” Thibault wrote in a research note. “We think this is short-sighted, especially since enrollment is expected to resume soon, but acknowledge wariness about anything going wrong with a key product and potential TAM-expanding effort.”

News of the AVANT GUARD trial delay comes a day after the company reported winning a nod for the Farawave Nav Ablation Catheter. The technology provides visualization for Farapulse procedures.

The PFA space is one of the hottest sectors in medtech. Boston Scientific is competing with Medtronic, which was the first company to win FDA approval in the space, and Johnson & Johnson.

Boston Scientific won FDA approval for the Farapulse earlier this year.

About the Author

Omar Ford

Omar Ford is a veteran reporter in the field of medical technology and healthcare journalism. As Editor-in-Chief of MD+DI (Medical Device and Diagnostics Industry), a leading publication in the industry, Ford has established himself as an authoritative voice and a trusted source of information.

Ford, who has a bachelor's degree in print journalism from the University of South Carolina, has dedicated his career to reporting on the latest advancements and trends in the medical device and diagnostic sector.

During his tenure at MD+DI, Ford has covered a wide range of topics, including emerging medical technologies, regulatory developments, market trends, and the rise of artificial intelligence. He has interviewed influential leaders and key opinion leaders in the field, providing readers with valuable perspectives and expert analysis.

 

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