Cardiologist makes history with first commercial implant of new pacing lead for LBBAP
Commercial implants of Biotronik’s Solia CSP S pacing lead are officially underway in the United States after the device was approved by the U.S. Food and Drug Administration (FDA).
Electrophysiologist Xiaodong Zhang, MD, PhD, director of the Moses EP Lab at Montefiore Health System, performed the first commercial implant of the newly approved device.
“Left bundle branch area pacing (LBBAP) offers many physiological and clinical benefits for patients but has been historically constrained by the use of legacy pacing leads,” Zhang explained in a statement. “The Solia CSP S lead has been an important step forward for these procedures, and I am grateful to be the first to implant this commercially in the USA.”
The first FDA approval of its kind
The Solia CSP S includes both a stylet-driven lead platform and a fixed helix with a brand new screw design. It was approved in February to be implanted in the patient’s left bundle branch area. While Medtronic, Boston Scientific, Abbott and Biotronik have all secured FDA approvals for devices capable of LBBAP in the past, the Solia CSP S is the first pacing lead specifically developed with conduction system pacing (CSP) in mind to receive such an approval.
“CSP represents the future of physiologic pacing, and Solia CSP S is the first of a new generation of LBBAP-specific solutions,” Ryan Walters, president of Biotronik US, said in the same statement. “It reflects our focus on delivering purpose‑built technologies that empower clinicians and elevate the standard of care for patients around the world.”
The Solia CSP S pacing lead for LBBAP. Image courtesy of Biotronik.
The rise LBBAP is one of modern cardiology’s biggest trends. Electrophysiologists see it as a way to achieve superior electrical resynchronization and easier procedures. In addition, Biotronik has said the Solia CSP S should provide clinicians with improved steerability and reduce preparation time prior to treatment
Biotronik plans on offering hands-on demonstrations of the Solia CSP S pacing lead during Heart Rhythm 2026 in Chicago.
More momentum for Biotronik
Biotronik has also announced the initiation of a new global study focused on the safety and evaluation of its LivIQ leadless pacemaker system. This next-generation device was built to provide patients with atrioventricular-synchrony with electrical far-field sensing. Researchers plan on enrolling approximately 325 patients across 60 sites around the world.
“We are one step closer to providing clinicians with a more intuitive and capable single‑device solution in leadless pacing,” Andreas Hecker, Biotronik’s chief technology officer, said in a statement. “LivIQ brings together two key advances that address distinct clinical needs. It combines an easy‑to‑handle catheter design that simplifies implantation, and a novel sensing concept that enhances therapy performance across more scenarios.”
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.