The first procedures under the study were performed in Japan. Credit: Biotronik.

BIOTRONIK has commenced its global pivotal trial assessing the LivIQ leadless pacemaker system, a next-generation single device solution intended for delivering atrioventricular (AV) synchrony through advanced electrical far field sensing.

The first procedures under this study were performed at the Kokura Memorial Hospital and the National Cerebral and Cardiovascular Center (NCVC) in Japan.

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The prospective multi-centre BIO-LivIQ trial will enrol 325 patients across 60 sites worldwide. The study aims to assess the safety, pacing performance, AV-synchrony behaviour, and quality-of-life outcomes.

These results will support global regulatory submissions for the LivIQ system.

LivIQ utilises far-field sensing technology to detect atrial activity electrically and facilitate a single device ventricular dual demand (VDD) mode.

The design supports AV synchrony in broad clinical scenarios. Additionally, the system’s manoeuvrable catheter is engineered for precise control and predictable placement during implantation.

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

“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 continue seeking solutions that reduce complications from traditional pacemaker pockets, infection risks, and invasive procedures. Leadless pacing is designed as an important emerging therapy to address these requirements.

In February 2024, Biotronik launched the Micro Rx catheter, a new device for enhancing guidewire support during percutaneous coronary interventions, in the US.

The rapid exchange microcatheter is produced by Interventional Medical Device Solutions (IMDS) and exclusively distributed by Biotronik.