MARLBOROUGH, Mass., Sept. 17, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval to expand the indication for current-generation INGEVITY™+ Pacing Leads – thin wires placed inside the heart and connected to an implantable device – to include conduction system pacing (CSP) and sensing of the left bundle branch area (LBBA) when connected to a single- or dual-chamber pacemaker.

Boston Scientific Corporation received U.S. Food and Drug Administration (FDA) approval to expand the indication for current-generation INGEVITY™+ Pacing Leads – thin wires placed inside the heart and connected to an implantable device – to include conduction system pacing (CSP) and sensing of the left bundle branch area (LBBA) when connected to a single- or dual-chamber pacemaker.
Boston Scientific Corporation received U.S. Food and Drug Administration (FDA) approval to expand the indication for current-generation INGEVITY™+ Pacing Leads – thin wires placed inside the heart and connected to an implantable device – to include conduction system pacing (CSP) and sensing of the left bundle branch area (LBBA) when connected to a single- or dual-chamber pacemaker.
Pacing of the LBBA is an alternative to traditional right ventricular pacing for the treatment of symptomatic bradycardia, a condition in which the heart beats too slowly. Through this pacing approach, which uses the heart's natural electrical system, a lead is placed in the LBBA of the heart's conduction system. This technique may promote greater ventricular synchrony and reduce the long-term risk of heart failure associated with traditional right ventricular pacing.1

"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, Cardiac Rhythm Management and Diagnostics, 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."

Clinical evidence submitted to the FDA to support the expanded indication included data from approximately 400 patients from the INSIGHT-LBBA study – an analysis of INGEVITY+ pacing leads that were previously implanted in the LBBA for anti-bradycardia pacing – and supplemented with bench testing and LATITUDE™ Programming System data.

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