FDA approves expanded indication for pacing leads to include conduction pacing of LBB area
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Key takeaways:
- The FDA approved an expanded indication for Boston Scientific’s pacemaker leads.
- The expanded indication includes conduction system pacing and left bundle branch area sensing.
Boston Scientific announced it received FDA approval to expand the indication for its pacing leads to include conduction system pacing of the left bundle branch area when connected to a single- or dual-chamber pacemaker.
The expanded approval is based on data from INSIGHT-LBBA study, which included approximately 400 patients who were previously implanted (Ingevity+) in the left bundle branch (LBB) area for anti-bradycardia pacing.
Anti-bradycardia pacing in the LBB area is an alternative to the traditional approach of right ventricular pacing and can reduce risk for HF due to promotion of ventricular synchrony, according to a press release issued by the company.
The leads are driven by a stylet during placement for positioning within the heart and allows for continuous pacing and impedance monitoring, according to the release.
"This expanded indication provides physicians using the Ingevity+ Pacing Lead the flexibility to determine the most appropriate pacing strategy based on individual patient characteristics," Kenneth Stein, MD, senior vice president and global chief medical officer at Boston Scientific, said in the release. "Data has demonstrated this lead to be safe and effective for LBB [area] 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 expanded indication follows the launch of the company’s conduction system pacing portfolio (OneLINK Splitter Cable; Ingevity+ helix locking tool; and site-selective pacing delivery catheters) designed to support placement of the pacing lead in the LBB area.
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