PARIS, France, 18 September 2025 – 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.1
"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," said Angelo Auricchio, M.D., Ph.D., chief medical officer for Rhythm Management EMEA, 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 study2. 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 Dr Bertini, M.D., Ph.D., head of Electrophysiology at University Hospital S. Anna in 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.”
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.
More information on the INGEVITY+ Pacing Lead is available here.
About Boston Scientific
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and connect on LinkedIn.
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1 Sharma P et al. Clinical outcomes of left bundle branch area pacing compared to right ventricular pacing: Results from the Geisinger-Rush Conduction System Pacing Registry. Heart Rhythm. 2021; 19:3-11
2 Friedman D et al. Performance of an Active FixationStylet-Driven Lead in Left Bundle Branch Area Pacing: Results from INSIGHT-LBBA. Heart Rhythm 2025