BIOTRONIK Announces First U.S. Implant of Investigational Next-Generation Leadless Pacemaker LivIQ Leadless Pacemaker Designed to Enable Advanced Far-Field Sensing for AV Synchronous Pacing
BIOTRONIK, a global leader in cardiovascular medical technology, today announced the first U.S. implant of its LivIQ leadless pacemaker as part of the BIO-LivIQ global pivotal clinical trial. This next-generation single-device solution is developed to deliver atrioventricular (AV) synchrony through advanced electrical atrial far-field sensing. The implant was successfully performed by James Ip, MD, FACC, FHRS, Professor of Medicine, Director of Cardiac Pacing and Implantable Devices and Principal Investigator at Weill Cornell Medicine and a Cardiac Electrophysiologist at NewYork-Presbyterian/Weill Cornell Medical Center.
“Our team is pleased to be the first to implant the LivIQ device in the United States,” said James Ip, MD. “This novel leadless pacemaker that is designed to provide AV synchronous pacing using a single device could potentially advance the field of leadless pacing.”
LivIQ leverages novel far-field sensing technology to electrically detect atrial activity and is engineered to enable a single-device VDD mode. This advanced sensing approach supports AV synchrony across a broad range of clinical scenarios.
In addition to its far-field sensing capabilities, LivIQ features a highly maneuverable catheter designed to provide precise control and predictable placement – supporting a smooth, streamlined implantation experience.
“We designed LivIQ to address critical gaps in current leadless technologies: a single-device leadless solution that combines intuitive catheter handling with AV synchrony, particularly when an elevated heart rate and higher cardiac output is required,” said Dr. David Hayes, Chief Medical Officer, BIOTRONIK. “We are pleased to see the first U.S. implant completed and look forward to continued enrollment as we work to bring this needed technology to clinicians worldwide.”
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.
Caution: Investigational Device. Limited by U.S. law to investigational use.
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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 harmonize 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.
