Boston Scientific’s Farapulse Pulsed-Field Ablation (PFA) system is helping it to bolster its position in the electrophysiology market in the US and EMEA region. Credit: Michael Vi/Shutterstock.

The US Food and Drug Administration (FDA) has approved a label expansion for Boston Scientific’s current-generation Ingevity+ pacing leads.

The label expansion allows for the pacing leads to be used to perform two novel cardiac pacing modalities, conduction system pacing (CSP) and sensing of left bundle branch pacing (LBBA) when connected to a single- or dual-chamber pacemaker.

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“This approval strengthens our broader initiative to provide physicians with LBBA-specific tools and educational resources, while reinforcing our commitment to developing safe and effective pacing technologies,” said Scott Olson, senior vice president and president of cardiac rhythm management and diagnostics at Boston Scientific.

“We believe the expanded indication for the INGEVITY+ Pacing Lead will enhance the implant experience for physicians and connect this technology to the growing number of patients who can benefit from LBBA pacing.”

CSP allows for direct activation of the heart’s conduction system by the pacing stimulus. The novel pacing modality has gained traction in recent years. LBBA is also a novel pacing modality, that has emerged as an alternative to traditional right ventricular pacing, as it reduces the long-term risk of heart failure that is associated with the latter.

The FDA expanded label approval was based on the data from the INSIGHT-LBBA study along with bench testing and LATITUDE programming system data. The retrospective, multi-center, US-only observational INSIGHT-LBBA trial (NCT06014866) collected data from 400 patients who were implanted in the LBBA using Ingevity+ leads.

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Invevity+ lead was first approved by the US FDA for use with pacemakers and defibrillators in 2019. The pacing leads are 6F (2.0 mm) steroid-eluting, endocardial pace/sense leads designed for permanent implantation for either atrial or ventricular applications.

According to GlobalData analysis, the global market for pacemakers is expected to grow from being worth about $4bn in 2023 to over $5.7bn by 2033. Another innovation in the sector is the dual-chamber leadless pacemakers. The market segment for the leadless pacemakers is forecasted to grow at a compound annual growth rate (CAGR) of 8.95% from $185.9m in 2023 to $438m in 2033