Why Medical Devices Behemoth Boston Scientific Shares Are Rising Friday

Boston Scientific Corporation BSX said it expects FARAPULSE Pulsed Field Ablation (PFA) System to get FDA approval in the first quarter of 2024.

The Medtech behemoth said it has initiated the AVANT GUARD clinical trial to evaluate the safety and effectiveness of the FARAPULSE PFA System as a first-line treatment for persistent atrial fibrillation.

The randomized AVANT GUARD trial will enroll more than 500 patients diagnosed with persistent atrial fibrillation at up to 75 sites globally. 

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Patients in the study will be randomized to undergo pulmonary vein isolation (PVI) and left atrial posterior wall ablation using the FARAPULSE PFA System or receive AAD treatment and followed for three years.

It is the only trial to study the use of PFA as frontline therapy in patients with this form of atrial fibrillation.

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

"With nearly 40,000 patients treated to date in clinical and commercial settings, the FARAPULSE PFA System continues to demonstrate a promising safety and effectiveness profile, upon which this study seeks to build," said Dr. Brad Sutton, chief medical officer of Atrial Fibrillation Solutions, Boston Scientific.

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All patients in the trial will also be inserted with the Boston Scientific LUX-Dx Insertable Cardiac Monitor, the company said.

"The AVANT GUARD trial is exciting in that it has the potential to change clinical practice by advancing the therapy to be utilized as an earlier treatment for persistent AF, which may lead to better long-term outcomes and establish the FARAPULSE PFA System as the preferred method for treating the disease," Sutton added.

In the third quarter of 2023, Boston Scientific finished enrolling participants for the initial phase of the ADVANTAGE AF clinical trial, which investigates the system's treatment efficacy for drug-refractory symptomatic persistent AF. 

Additionally, the company initiated enrollment in an extension arm of the study to assess the safety and effectiveness of the FARAPOINT PFA Catheter in adjunctive use for cavotricuspid isthmus (CTI) ablations, a procedure employed to treat atrial flutter.

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Price Action: BSX shares are trading higher by 1.31% to $57.02 premarket on the last check Friday.

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