Boston Scientific has announced the resumption of its Avant Guard clinical trial, designed to evaluate the Farapulse pulsed field ablation (PFA) system as a first-line treatment for persistent atrial fibrillation (AFib). This follows a temporary pause in enrollment to investigate unspecified observations within the study.
The Avant Guard trial is a pivotal study comparing Boston Scientific's Farapulse PFA system against anti-arrhythmic drugs in patients with persistent AFib, a condition characterized by irregular heartbeats lasting more than a week. The trial aims to address a significant unmet need, as the currently FDA-approved indication for Farapulse is limited to paroxysmal (intermittent) AFib resistant to drug therapies.
"The assessment was completed, and we are initiating the restart of enrollments. We look forward to completing enrollment in the [Avant Guard] trial in the coming months and will continue to follow the patients per the trial protocol," stated Chanel Hastings, a spokesperson for Boston Scientific.
Strategic Implications and Market Context
The pursuit of a persistent AFib indication places Boston Scientific in direct competition with Medtronic, whose Pulseselect PFA system already holds FDA approval for both paroxysmal and persistent AFib in drug-refractory patients. Johnson & Johnson recently entered the PFA market with its Varipulse system, approved for paroxysmal AFib.
Boston Scientific is evaluating Farapulse in two distinct persistent AFib patient populations: those who are drug-refractory and those who are drug-naive (patients who have not received prior drug treatment). The Avant Guard trial focuses on the latter group, representing patients who are not currently indicated for ablation under existing treatment guidelines. The company initiated the Avant Guard trial in December of last year.
PFA Technology and Clinical Advantages
Pulsed field ablation has emerged as a promising alternative to traditional radiofrequency and cryoablation methods for treating AFib. AFib is a prevalent condition that elevates the risk of blood clots and stroke, affecting millions worldwide. PFA utilizes short bursts of electrical pulses to selectively ablate malfunctioning cardiac cells, thereby restoring normal heart rhythm while minimizing thermal damage to surrounding tissues.
Financial Performance and Future Outlook
Demand for the Farapulse system has been robust, driving a 177% year-over-year increase in Boston Scientific's electrophysiology sales during the third quarter. During an October earnings call, Boston Scientific's Chief Medical Officer, Kenneth Stein, addressed the Avant Guard trial pause, emphasizing that the decision was made to gain a deeper understanding of unanticipated observations that were not life-threatening. "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," Stein stated.
Boston Scientific anticipates submitting trial results from its Advantage AF trial, which studies Farapulse in drug-refractory persistent AFib patients, to the FDA later this quarter. The company expects to present the data in early 2025, with a potential label expansion anticipated in the second half of next year, according to CEO Mike Mahoney.
