Boston Scientific Receives FDA Approval for Expanded Indication of INGEVITY™+ Pacing Leads to Include Conduction System Pacing of the Left Bundle Branch Area

Boston Scientific Press Release

MARLBOROUGH, Mass., Sept. 17, 2024 -- Boston Scientific Corporation 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.

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.

"This expanded indication provides physicians using the INGEVITY+ Pacing Lead the flexibility to determine the most appropriate pacing strategy based on individual patient characteristics," said Kenneth Stein, M.D., senior vice president and global chief medical officer, Boston Scientific. "Data has demonstrated this lead to be safe and effective for LBBA pacing – a rapidly growing pacing technique – allowing us to provide a new therapeutic option on a proven lead that will further the quality of patient care."

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 the OneLINK™ Splitter Cable, INGEVITY+ Helix Locking Tool and site-selective pacing delivery catheters – which is designed to support the safe and effective placement of the INGEVITY+ Pacing Lead in the LBBA. The INGEVITY+ lead received FDA approval in 2019 for use with pacemakers and defibrillators.

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 and X, formerly Twitter.  

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