The expanded indication includes conduction system pacing (CSP) and sensing of the left bundle branch area (LBBA) when the pacing leads — thin wires placed inside the heart and connected to an implantable device — are connected to a single- or dual-chamber pacemaker. This news follows Biotronik’s expanded labeling for left bundle branch area pacing announced yesterday.
Pacing of the LBBA offers an alternative to traditional right ventricular pacing for treating symptomatic bradycardia. Through this approach, which uses the heart’s natural electrical system, a lead goes into the LBBA of the heart’s conduction system. This may promote greater ventricular synchrony and reduce the long-term risk of heart failure associated with traditional right ventricular pacing, according to a news release.
“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, SVP 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.”
More about the Boston Scientific Ingevity+ pacing leads
Ingevity+ is driven by a stylet during lead placement. This supports positioning the device into a desired location within the heart. It also allows for both continuous pacing and impedance monitoring. Such features can aid the appropriate placement and fixation, Boston Scientific says.
The expanded indication follows the launch of the company’s CSP portfolio. That portfolio includes the OneLink splitter cable, Ingevity+ helix locking tool and site-selective pacing delivery catheters, designed to support the safe and effective placement of Ingevity+ in the LBBA.
Ingevity+ initially received FDA approval in 2019 for use with pacemakers and defibrillators. Boston Scientific submitted clinical evidence to the FDA to support the expanded indication of its pacing system. That included data from approximately 400 patients from its INSIGHT-LBBA study. This analysis looked at Ingevity+ pacing leads previously implanted in the LBBA for anti-bradycardia pacing. It also featured 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 Dr. Kenneth Stein, SVP 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.”
