Biotronik Begins Study of LivIQ Leadless Pacemaker

Biotronik revealed the initiation of its global pivotal study assessing the LivIQ leadless pacemaker system. The next-gen device was designed to deliver atrioventricular (AV)-synchrony using advanced electrical far-field sensing.

The first implantations in this study were completed at the Kokura Memorial Hospital in Kitakyushu, Japan and the National Cerebral and Cardiovascular Center (NCVC) in Osaka, Japan.

“The BIOTRONIK leadless pacemaker system was remarkably straightforward to implant. Catheter navigation and deployment were intuitive, helping us to achieve excellent device positioning and initial results,” said Dr. Kenji Ando, Department of Cardiology at Kokura Memorial Hospital.

“I am pleased to see a highly compelling option emerging for a single device leadless pacemaker, promised to deliver strong AV-synchrony and long-term device performance,” added Dr. Kengo Kusano, study principal investigator at NCVC.

The prospective multicenter clinical investigation will enroll 325 patients at 60 sites across the world. The trial will assess device safety, pacing performance, AV-synchrony behavior, and quality-of-life outcomes to gather the evidence needed for global regulatory submissions.

LivIQ’s far-field sensing technology electrically detects atrial activity and allows a single-device VDD mode. The advanced sensing approach supports reliable AV synchrony in a variety of clinical scenarios, Biotronik said.

The device’s maneuverable catheter is designed for precise control and predictable placement for a smooth, streamlined implantation experience.

“We are one step closer to providing clinicians with a more intuitive and capable single‑device solution in leadless pacing,” said Dr. Andreas Hecker, chief technology officer at Biotronik. “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.”

Last month, received U.S. Food and Drug Administration (FDA) approval for its Solia CSP S pacing lead, growing access to a solution for Left Bundle Branch Area Pacing (LBBAP).