Boston Scientific Corporation (BSX) has secured FDA approval for an expanded indication of its INGEVITY+ Pacing Leads, enabling conduction system pacing (CSP) and sensing of the left bundle branch area (LBBA). This approval offers a new therapeutic option for patients with symptomatic bradycardia, a condition characterized by a slow heart rate, and may reduce the long-term risk of heart failure associated with traditional right ventricular pacing.
The INGEVITY+ Pacing Lead, a thin wire placed inside the heart and connected to an implantable device, is now indicated for pacing and sensing in the LBBA when connected to a single- or dual-chamber pacemaker. This technique involves placing a lead in the LBBA of the heart's conduction system, leveraging the heart's natural electrical pathways to promote greater ventricular synchrony.
Clinical Evidence and Benefits
The FDA's decision was supported by clinical evidence from the INSIGHT-LBBA study, which included data from approximately 400 patients who had previously received INGEVITY+ pacing leads in the LBBA for anti-bradycardia pacing. The study was supplemented with bench testing and data from the LATITUDE Programming System.
According to Kenneth Stein, M.D., senior vice president and global chief medical officer at Boston Scientific, this expanded indication provides physicians with the flexibility to determine the most appropriate pacing strategy based on individual patient characteristics. He noted that data has demonstrated the lead's safety and effectiveness for LBBA pacing, a rapidly growing technique.
INGEVITY+ Features and CSP Portfolio
The INGEVITY+ Pacing Lead is designed with a stylet-driven placement system, facilitating precise positioning within the heart. It also allows for continuous pacing and impedance monitoring, aiding in appropriate placement and fixation. The expanded indication follows the launch of Boston Scientific's CSP portfolio, which includes the OneLINK Splitter Cable, INGEVITY+ Helix Locking Tool, and site-selective pacing delivery catheters, all designed to support the safe and effective placement of the INGEVITY+ Pacing Lead in the LBBA.
Addressing Bradycardia
Bradycardia affects a significant portion of the population, particularly the elderly, and can lead to fatigue, dizziness, and fainting. Traditional right ventricular pacing, while effective in treating bradycardia, has been associated with an increased risk of heart failure in the long term. LBBA pacing offers a potential solution by utilizing the heart's natural conduction system, promoting more synchronized ventricular contraction and potentially reducing the risk of heart failure.
Scott Olson, senior vice president and president, Cardiac Rhythm Management and Diagnostics at Boston Scientific, stated that this approval strengthens their initiative to provide physicians with LBBA-specific tools and educational resources, reinforcing their commitment to developing safe and effective pacing technologies. The company believes the expanded indication will enhance the implant experience for physicians and connect this technology to more patients who can benefit from LBBA pacing.
The INGEVITY+ lead initially received FDA approval in 2019 for use with pacemakers and defibrillators, marking another step forward in cardiac rhythm management.
