FDA approves new Biotronik pacing lead for LBBAP
Biotronik has secured U.S. Food and Drug Administration (FDA) approval for its Solia CSP S pacing lead for left bundle branch area pacing (LBBAP).
The newly approved device was designed and developed specifically with LBBAP in mind. It includes both a stylet-driven lead platform and a fixed helix with a brand new screw design.
“With FDA approval, we reinforce our dedication to continued innovation in the critical field of conduction system pacing,” Ryan Walters, president of Biotronik, said in a statement.
This approval was based in part on early data from the second arm of the ongoing BIO-CONDUCT investigational device exemption (IDE) trial. Researchers tracked the safety and effectiveness of using stylet-driven leads for conduction system pacing in more than 100 U.S. patients. The previous arm of the study had focused on using Biotronik’s Solia S device for LBBAP.
“FDA approval for the Solia CSP S pacing lead represents an important step forward in the continued advancement of physiologic pacing,” Larry Chinitz, MD, director of cardiac electrophysiology at NYU Langone's Heart Rhythm Center and principal investigator of the BIO-CONDUCT study, said in the same statement. “Investigator experiences from the BIO-CONDUCT IDE trial highlight the value of a product specifically engineered for LBBAP.”
“The Solia CSP S pacing lead provides a purpose-built solution long overdue for conduction system pacing,” added Christopher Liu, MD, medical director of cardiac electrophysiology services for the New York-Presbyterian–Weill Cornell Network. “With the combination of a stylet-driven platform and fixed helix, Solia CSP S is a new generation lead that can now be used to achieve physiologic pacing for our patients.”
LBBAP pacing gaining more momentum
The use of LBBAP is one of cardiology’s biggest trends, with electrophysiologists placing a single lead in the interventricular septum. This is believed to offer multiple benefits compared to more traditional pacing techniques, including superior electrical resynchronization and simplified procedures. Medtronic, Boston Scientific, Abbott and Biotronik have all secured FDA approvals for devices capable of LBBAP in the past. However, Biotronik celebrated this latest approval as the first time the agency had signed off on an electrophysiology device built with LBBAP in mind from the very beginning.
“Solia CSP S reflects our commitment to advancing physiologic pacing and equipping clinicians with solutions that enhance patient outcomes,” Walters said.
Biotronik plans on offering hands-on demonstrations of the Solia CSP S pacing lead during Heart Rhythm 2026 in Chicago.
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.