Boston Scientific Pauses Enrollment In Farapulse Study In Drug-Naive Patients With Irregular Heart Rhythm

In December 2023, Boston Scientific Corporation (NYSE: BSX) initiated the AVANT GUARD trial to evaluate the safety and effectiveness of the FARAPULSE Pulsed Field Ablation (PFA) System as a first-line treatment for persistent atrial fibrillation (AF).

Persistent atrial fibrillation (AFib) is a condition where an irregular heart rhythm lasts for more than a week.

The company said that it is the only trial to study using PFA as frontline therapy in patients with this form of AF.

Outcomes of ablation with the FARAPULSE PFA System—a nonthermal treatment in which electric fields selectively ablate heart tissue—will be compared to outcomes following the use of anti-arrhythmic drug (AAD) therapy, which is commonly prescribed for patients living with persistent AF.

Also Read: Boston Scientific Q3 Earnings: Revenue And EPS Beat, Lifts Annual Forecast On Strong Demand For Heart Devices.

The randomized AVANT GUARD trial was expected to enroll over 500 patients.

In its third-quarter earnings investor call, Boston Scientific’s Michael Mahoney, Chairman and CEO, said, “As we have neared the end of this enrollment, we have elected to temporarily pause the trial to assess a few unanticipated observations. It is our intention to resume enrollments in the near term.”

The CEO added that due to a few unanticipated observations in the trial, which is studying an entirely new population, which is drug-naive patients with persistent AF, which FARAPULSE is not currently indicated to treat.

The company has temporarily paused enrollment until it better understands the observations. The company added that none of the observations were life-threatening.

Kenneth Stein – Senior Vice President, Global Chief Medical Officer said, “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.”

“I just want to emphasize that the patient population we’re studying in AVANT GUARD—which is drug-naive, persistent AF patients—has not previously been studied,” said Stein. “It is a population that’s not indicated for ablation today under guidelines, and it’s not the population that’s being treated today with the Farapulse system.”

Price Action: BSX stock is down 1.52% at $86.67 at last check Wednesday.

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