Biotronik has today announced the successful first-in-human implantations of its LivIQ leadless pacemaker system as part of the BIO|CONCEPT.LivIQ study—a premarket clinical investigation designed to evaluate the system’s preliminary safety and performance.
The initial procedures were performed in Australia by Paul Gould at Princess Alexandra Hospital, Brisbane, as well as Stewart Healy and Emily Kotschet at Victorian Heart Hospital, Melbourne. The physicians highlighted the system’s “superior handling” during implantation, according to a Biotronik press release.
“I was extremely impressed with how easy the delivery system was to use,” Gould said. “It enables accurate and stable positioning with an added ability to simply reposition if required.”
Additionally, Healy and Kotschet emphasised the periprocedural visibility of both the device and the delivery system, adding: “Biotronik put a lot of thought into this. The visibility of the tines and the tether are excellent. The delivery system is intuitive, and easy to use.”
The LivIQ leadless pacing system is described by Biotronik as the world’s first intracardiac pacemaker to use atrial electrical far-field sensing. It enables atrioventricular-synchronous pacing at rest and during exercise with a single cardiovascular implantable electronic device (CIED). The device has been designed to provide reliable rate adaptation without compromising device longevity, Biotronik adds.
“We plan to move into the global pivotal study in the coming months,” commented Andreas Hecker, chief technology officer at Biotronik. “Introducing DX technology to leadless pacing represents a major step forward in bradycardia therapy, and we are excited to bring it to patients worldwide soon.”
