- International BIO-LivIQ Study Will Generate Evidence for Global LivIQ Leadless Pacemaker Approvals
- Far-Field Sensing and AV-Synchronous Pacing Performance Will be Validated by Real World Clinical Data
BERLIN, March 24, 2026 /PRNewswire/ — BIOTRONIK today announced the initiation of its global pivotal study evaluating the LivIQ leadless pacemaker system. This next-generation single‑device solution is designed to deliver atrioventricular (AV)-synchrony using advanced electrical far‑field sensing.
First implantations within this study have been 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.
As a prospective multicenter clinical investigation, the BIO-LivIQ study will enroll 325 patients across 60 sites worldwide. The trial will evaluate device safety, pacing performance, AV-synchrony behavior, and quality-of-life outcomes to generate the evidence required for global regulatory submissions.
LivIQ continues BIOTRONIK’s long‑standing commitment to physiologic pacing. It uses proven far‑field sensing technology to electrically detect atrial activity and enable a single‑device VDD mode. This advanced sensing approach supports reliable AV synchrony across a broad range of clinical scenarios. Equally important, LivIQ’s highly maneuverable catheter is designed for precise control and predictable placement, creating 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.”
Clinicians seek solutions to avoid complications related to the pacemaker’s pocket, infection risks, and an invasive experience. Leadless pacing continues to emerge as an important therapy option and is designed to address these growing needs.
CAUTION – Investigational device. Limited to federal (United States) law to investigational use.
About BIOTRONIK
For over 60 years, BIOTRONIK has stood at the forefront of medical technology, pioneering breakthrough innovations that are transforming the lives of millions affected by heart disease and chronic pain. Rooted in a deep purpose to seamlessly harmonise technology with the human body, we engineer trusted, life-changing therapies through our advanced active implants in Cardiac Rhythm Management, Monitoring, and Neuromodulation, while providing cutting-edge solutions in Electrophysiology. From creating Germany’s first pacemaker in 1963 to breaking new ground in digital technologies and Conduction System Pacing today, BIOTRONIK is continuously raising the bar for quality, performance, and innovation. Headquartered in Berlin, our global reach spans over 100 countries across the Americas, EMEA, and Asia—bringing bold, future-ready solutions that are shaping the next generation of medical technology.
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