First European Implants of BIOTRONIK Leadless Pacemaker LivIQ BIO-LivIQ study evaluates next‑gen leadless pacer to address limitations of current leadless pacing systems
BIOTRONIK, a global leader in medical technology, today announced the first European implantations of its LivIQ leadless pacemaker system as part of the BIO-LivIQ study. The study’s objective is to evaluate the safety and efficacy of LivIQ, including its ability to deliver atrioventricular (AV) synchronous pacing. By enabling AV synchrony at rest and during exercise, LivIQ aims to better address real‑world patient needs, potentially benefiting a broader group of patients, including younger and more active individuals.
The procedures were performed by Prof. Christophe Garweg, BIO-LivIQ Steering Committee Member, Cardiologist and Interventional Electrophysiologist at the University Hospitals of Leuven, Belgium. Prof. Garweg recently presented research results at the Heart Rhythm Society (HRS) meeting confirming LivIQ’s AV synchrony performance in animal models. The study demonstrated safe implantation, stable electrical performance over 12 weeks, and consistent AV synchrony with atrial tracking rates up to 140 beats per minute.
“Leadless pacemaker technology is advancing rapidly. The expansion of implantation capabilities, driven by the emergence of new leadless devices, together with the entry of a third major player into the field, highlights that this technology is moving beyond narrowly defined indications toward broader clinical adoption. Following the demonstration of an excellent safety and efficacy profile in a preclinical model, the initiation of this first-in-human study is an important step to validate these findings in patients,” said Professor Christophe Garweg. “Preclinical results also showed that this miniaturized pacemaker enables effective atrioventricular synchronization. In patients who do not require atrial pacing, this may allow AV synchrony without the need for a dedicated atrial device, supporting the continued evolution of leadless pacing toward more physiologic cardiac rhythm management. With the start of patient implantations in the pivotal study, we can now begin to assess how these promising results translate into clinical practice.”
LivIQ is BIOTRONIK’s next‑generation investigational leadless pacemaker designed to enable AV synchrony through far‑field atrial electrical sensing. The BIO-LivIQ prospective multicenter will enroll 325 patients to evaluate device safety, pacing performance, AV-synchrony, and quality-of-life outcomes.
“Delivering reliable AV synchrony with a single device has long been one of the key challenges in leadless pacing therapy,” said Andreas Hecker, Chief Technology Officer at BIOTRONIK. “LivIQ is designed to meet this need. Following the first study implants in Japan, we are proud to see European centers support the evaluation of our unique solution.”
LivIQ is part of BIOTRONIK’s ongoing commitment to advance leadless pacing as a clinically meaningful alternative to transvenous systems, which are associated with lead-related complications and device pocket infection risks. The system is developed to retain the procedural and long‑term benefits of leadless implantation while enabling AV synchrony.
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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 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.
