Boston Sci Resumes AVANT GUARD PFA Trial

Boston Scientific is resuming enrollment in the AVANT GUARD pulsed-field ablation trial after a temporary pause.

The Marlborough, MA-based company stopped the trial in October because of a few unanticipated observations. Executives did not go into details about the nature of the observations but noted the trial was not paused because of any life-threatening events.

In an SEC filing, Boston Scientific said “the decision to resume enrollments in the trial was made following an assessment of observations within the trial and in conjunction with the study’s data monitoring committee.”

AVANT GUARD is looking at how Boston Scientific’s Farapulse PFA could treat a new patient population of drug-naïve persistent atrial fibrillation patients.

Currently, the Farapulse PFA is indicated for the isolation of pulmonary veins in the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (i.e., intermittent) atrial fibrillation and is a new alternative to standard-of-care thermal ablation treatment.

The company won FDA approval for Farapulse in late January. And a day after Boston Scientific paused the AVANT GUARD trial, it won a nod from FDA for the Farawave Nav Ablation Catheter,  a technology that provides visualization for Farapulse procedures.

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Most recently, Boston Scientific announced an acquisition to help boost its PFA offerings. The company said it signed an agreement to acquire Cortex, a developer of a diagnostic mapping solution, that may identify triggers and drivers outside of the pulmonary veins that are foundational to Afib.

It might seem as if Boston Scientific is moving fast in its PFA efforts – but so are its competitors in the space. Medtronic, the first company to win FDA approval for a PFA device to treat AFib recently won FDA approval for the Affera Mapping and Ablation System.

The Affera Mapping and Ablation System with the Sphere-9 Catheter is indicated for the treatment of persistent atrial fibrillation and for RF ablation of cavotricuspid isthmus (CTI) dependent atrial flutter. Medtronic inherited the device when it acquired Affera in 2022.

Johnson & Johnson jumped into the PFA frenzy last week when it won FDA approval for Varipulse.