Boston Scientific's Farapulse Eyes Stronger US Market Position With Potential FDA Approval

Boston Scientific Corp BSX will present results from ADVENT pivotal trial for its Farapulse Pulsed Field Ablation (PFA) system at the 2023 European Society of Cardiology Congress on 27 August.

ADVENT is a randomized clinical trial comparing Farapulse PFA to thermal ablation. 

ADVENT compares Farapulse to standard-of-care RF ablation (RFA) and cryoballoon ablation without using anti-arrhythmic drugs. 

Farapulse has a CE Mark and is currently being sold in Europe, and the Needham analysts Mike Matson, David Saxon, and Joseph Conway say ADVENT to support an FDA approval. 

The analysts project the global electrophysiology market, valued at approximately $7.6 billion in 2022, to reach $9.4 billion by 2024. 

The 2022 global electrophysiology market shares were distributed as follows: Johnson & Johnson JNJ held 48%, Abbott ABT had 25%, Medtronic Plc MDT secured 17%, Boston Scientific garnered 8%, and others accounted for 2%. 

The potential FDA approval of Farapulse might bolster Boston Scientific's position in the electrophysiology market, given that it could become the second PFA system available in the US.

Boston Scientific's electrophysiology operations currently contribute about 5% of its revenue. 

Based on the enrollment period from March 2021 to June 2022, the analysts also speculate that the participant count might not have reached 750. 

If the assumption holds, and considering that BSX hasn't hinted at halting the trial due to ineffectiveness, it's likely that the trial successfully met its primary objectives. 

Though Needham is not anticipating superiority, should it be achieved, it would mark a significant triumph for Farapulse.

Price Action: BSX shares are up 0.15% at $50.94 on the last check Friday.