Boston Scientific’s INGEVITY™+ Leads Get FDA Approval For Advanced Pacing

Boston Scientific Corporation has obtained FDA approval to extend the use of its current-generation INGEVITY™+ Pacing Leads. These slender wires, which are implanted in the heart and linked to an implantable device, can now be used for conduction system pacing (CSP) and for monitoring the left bundle branch area (LBBA) when paired with either a single- or dual-chamber pacemaker.

LBBA pacing offers an alternative to conventional right ventricular pacing for treating symptomatic bradycardia, a condition characterized by a slow heartbeat. This method leverages the heart’s natural electrical pathways by placing a lead in the LBBA within the heart's conduction system. It aims to enhance ventricular synchrony and potentially lower the risk of long-term heart failure compared to traditional right ventricular pacing

To back the expanded indication, clinical evidence provided to the FDA encompassed data from around 400 patients involved in the INSIGHT-LBBA study. This research focused on INGEVITY+ pacing leads previously implanted in the LBBA for anti-bradycardia pacing. The evidence was further supported by bench testing and data from the LATITUDE™ Programming System.

The INGEVITY+ Pacing Lead features a stylet that assists in placing the device precisely within the heart, ensuring both continuous pacing and impedance monitoring. This capability enhances correct positioning and secure fixation. This expanded indication follows the introduction of Boston Scientific’s CSP portfolio, which includes the OneLINK™ Splitter Cable, INGEVITY+ Helix Locking Tool, and site-selective pacing delivery catheters, all aimed at ensuring the safe and effective placement of the INGEVITY+ Pacing Lead in the LBBA. The INGEVITY+ lead has been FDA-approved since 2019 for use with pacemakers and defibrillators.

Scott Olson, senior vice president and president, Cardiac Rhythm Management and Diagnostics, Boston Scientific, said in a statement, "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. 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."

Kenneth Stein, M.D., senior vice president and global chief medical officer, Boston Scientific, stated "This expanded indication provides physicians using the INGEVITY+ Pacing Lead the flexibility to determine the most appropriate pacing strategy based on individual patient characteristics. 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."