Boston Scientific has received CE-mark approval to expand the indication for its current-generation Ingevity+ pacing leads—thin wires that are implanted in the heart and connected to a pacemaker. This expansion now includes conduction system pacing (CSP) and sensing of the left bundle branch area (LBBA) of the heart when connected to a single- or dual-chamber pacemaker.
“The CE-mark expansion enhances the clinical utility of the Ingevity+ pacing lead by supporting its use in the LBBA—an approach backed by compelling real-world and clinical evidence,” said Angelo Auricchio, chief medical officer for Rhythm Management Europe, Middle East and Africa (EMEA) at Boston Scientific. “Combined with our expanded CSP portfolio, we can deliver a more tailored, physiological pacing solution to meet the evolving needs of physicians and patients.”
The expanded indication was supported by a comprehensive body of clinical evidence, including data from more than 1,100 patients in the INSIGHT-LBBA study, Boston Scientific claims. This analysis specifically examined Ingevity+ pacing leads previously implanted for anti-bradycardia pacing in the LBBA, further supplemented by robust bench testing and Latitude programming system data.
“This approval represents a significant advancement in cardiac pacing therapy, which enhances our capacity to provide a pacing solution more aligned with the body’s natural needs for patients experiencing symptomatic bradycardia,” said Matteo Bertini (University Hospital Saint Anna, Ferrara, Italy). “This technology offers the potential for improved left ventricular synchrony and function, which may lead to a reduction in heart failure-related hospitalisation and an overall better quality of life, while allowing hospitals to increase treatment options and contribute to superior patient outcomes.”
According to Boston Scientific, the Ingevity+ pacing lead is driven by a stylet during lead placement, which supports positioning the device into a desired location within the heart, and allows for both continuous pacing and impedance monitoring—key features that can aid appropriate placement and fixation. This expanded indication follows the launch of the Boston Scientific CSP portfolio—inclusive of the helix locking tool as well as site-selective pacing (SSPC) delivery catheters—which is designed to support the safe and effective placement of the Ingevity+ pacing lead in the LBBA.
