FDA approves Boston Scientific leads for left bundle branch area pacing

Michael Walter | September 18, 2024 | Cardiovascular Business | Heart Failure

Image courtesy of Boston Scientific.

Boston Scientific has received U.S. Food and Drug Administration (FDA) approval for its Ingevity+ pacing leads to be used for left bundle branch area pacing (LBBAP) when connected to a single- or dual-chamber pacemaker.

The Ingevity+ leads, first approved by the FDA in 2019, are driven by a stylet during placement. Their design includes a flexible neck and IROX-coated tip on the electrode. According to Boston Scientific, the company has already sold nearly 700,000 Ingevity+ leads worldwide.

LBBAP is a relatively new alternative to biventricular pacing (BVP) used by electrophysiologists to reduce the risk of heart failure in patients with persistent symptoms after guideline-directed medical therapy. This treatment strategy is rapidly gaining momentum in the United States, with more and more clinical trials focusing on its potential safety and benefits. Biotronik just received FDA approval for its own lead technology to be used for LBBAP Sept. 16.

The FDA’s decision was largely based on data from the INSIGHT-LBBA clinical trial, which explored data from 400 bradycardia patients.

“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,” Scott Olson, senior vice president and president of cardiac rhythm management and diagnostics at Boston Scientific, said in a statement. “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 LBBAP.”

“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,” added Kenneth Stein, MD, senior vice president and global chief medical officer at Boston Scientific.

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Michael Walter, Managing Editor

Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.

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