Boston Scientific receives CE mark for expanded indication of INGEVITY™+ Pacing Leads
Boston Scientific Corporation (NYSE: BSX) 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.
LBBA pacing offers a physiological alternative to traditional right ventricular pacing for patients with symptomatic bradycardia — a condition where the heart beats too slowly.
This approach utilises the heart’s natural electrical system by placing a lead in the LBBA, which may promote greater ventricular synchrony and potentially reduce the long-term risk of heart failure associated with conventional right ventricular pacing.
Angelo Auricchio, M.D., Ph.D. is chief medical officer for Rhythm Management EMEA, Boston Scientific.
Auricchio said: “The CE mark expansion enhances the clinical utility of the INGEVITY+ Pacing Lead by supporting its use in the left bundle branch area — an approach backed by compelling real-world and clinical evidence.
“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.
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.
Dr Bertini, M.D., Ph.D., head of Electrophysiology at University Hospital S. Anna in Ferrara, Italy.
Bertini said: “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.
“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.”
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.
The expanded indication follows the launch of the Boston Scientific CSP portfolio — inclusive of Helix Locking Tool, and site-selective pacing (SSPC) delivery catheters, which is designed to support the safe and effective placement of the INGEVITY+ Pacing Lead in the LBBA.
