US-based biomedical engineering company Boston Scientific has received US Food and Drug Administration (FDA) approval for an expanded indication for INGEVITY + pacing leads.
The INGEVITY+ lead was initially approved in 2019, for use with pacemakers and defibrillators.
The expanded approval will include conduction system pacing (CSP) and sensing the left bundle branch area (LBBA) when connected to a single- or dual-chamber pacemaker.
According to Boston Scientific, pacing of the LBBA is an alternative to traditional right ventricular pacing to treat symptomatic bradycardia, a condition in which the heart beats too slowly.
The new pacing approach, which involves placing a lead in the LBBA of the heart’s conduction system, uses the heart’s natural electrical system.
The technique may enhance ventricular synchrony and reduce the long-term risk of heart failure associated with traditional right ventricular pacing, said the biomedical engineering company.
Boston Scientific senior vice president and cardiac rhythm management and diagnostics president Scott Olson said: “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.”
The expanded approval is supported by the clinical evidence submitted to the FDA, including data from the INSIGHT-LBBA study, an analysis of INGEVITY+ pacing leads in 400 patients.
In the study, the pacing leads were previously implanted in the LBBA for anti-bradycardia pacing and supplemented with bench testing and LATITUDE Programming System data.
The expanded indication follows the launch of the Boston Scientific CSP portfolio, which includes the OneLINK Splitter Cable, INGEVITY+ Helix Locking Tool and site-selective pacing delivery catheters.
Boston Scientific senior vice president and global chief medical officer Kenneth Stein said: “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.”
In a separate development, Boston Scientific announced the closing of its acquisition of Silk Road Medical, a California-based medical device company.
Silk Road Medical developed a new approach to stroke prevention and treating carotid artery disease through its minimally invasive transcarotid artery revascularisation (TCAR) procedure.
Boston Scientific acquired Silk Road Medical’s share capital at a purchase price of $27.50 per share, for a total enterprise value of around $1.18bn.
Boston Scientific vascular, peripheral interventions president Cat Jennings said: “Completing this acquisition enables Boston Scientific to strengthen our vascular technology solutions by bringing the innovative TCAR platform to a greater number of physicians and their patients through our significant commercial reach.
“The integration of the TCAR platform into our portfolio means we can offer a treatment option for patients suffering from carotid artery disease that can reduce the risk of stroke and lead to improved patient outcomes.”
