Biotronik has announced the initiation of a global pivotal study evaluating its LivIQ leadless pacemaker system—a single‑device solution designed to deliver atrioventricular (AV) synchrony using advanced electrical far‑field sensing.
The 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,” said Kenji Ando (Kokura Memorial Hospital, Kitakyushu, Japan). “Catheter navigation and deployment were intuitive, helping us to achieve excellent device positioning and initial results.”
“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 study principal investigator Kengo Kusano (NCVC, Osaka, Japan).
As a prospective, multicentre clinical investigation, the BIO-LivIQ study is set to enrol 325 patients across 60 sites worldwide. The trial will evaluate device safety, pacing performance, AV synchrony behaviour and quality-of-life outcomes to generate the evidence required for global regulatory submissions.
As per a company press release, LivIQ continues Biotronik’s longstanding commitment to physiologic pacing, using proven far‑field sensing technology to electrically detect atrial activity and enable a single‑device ventricular-ventricular delay (VDD) mode. This advanced sensing approach supports reliable AV synchrony across a broad range of clinical scenarios. Additionally, LivIQ’s highly manoeuvrable catheter is designed for precise control and predictable placement, creating a smooth, streamlined implantation experience, Biotronik further claims.
“We are one step closer to providing clinicians with a more intuitive and capable single‑device solution in leadless pacing,” commented 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.”
