Boston Scientific’s Ingevity+ Pacing Leads OK’ed for Expanded Label

Boston Scientific has earned U.S. Food and Drug Administration (FDA) approval to expand the indication of its current-generation Ingevity+ pacing leads to include conduction system pacing (CSP) and sensing of the left bundle branch area (LBBA) when connected to a single- or dual-lead chamber pacemaker.
 
Pacing of the LBBA is an alternative to traditional right ventricular pacing for the treatment of symptomatic bradycardia, a condition in which the heart beats too slowly. Through this pacing approach, which uses the heart’s natural electrical system, a lead is placed in the LBBA of the heart’s conduction system.
 
The Ingevity+ pacing lead is driven by a stylet during lead placement, which supports positioning the device into a desired location in the heart and allows both continuous pacing and impedance monitoring.
 
Clinical evidence submitted to the FDA to support the expanded indication included data from about 400 patients from the INSIGHT-LBBA study—an analysis of Ingevity+ pacing leads that were previously implanted in the LBBA for anti-bradycardia pacing—and supplemented with 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 Kenneth Stein, MD, senior VP 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.”