Biotronik Reports 1st U.S. Implant of Next-Gen LivIQ Leadless Pacemaker

Biotronik announced the first U.S. implantation of its LivIQ leadless pacemaker as part of the BIO-LivIQ global pivotal clinical trial.

The next-gen device delivers atrioventricular (AV) synchrony through advanced electrical far-field sensing. The implant was successfully done 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 utilizes far-field sensing tech to electrically detect atrial activity and was designed to enable a single-device VDD more. This sensing approach supports AV synchrony for a variety of clinical scenarios, Biotronik said. LivIQ also boasts a maneuverable catheter to provide precise control and predictable placement.

The BIO-LivIQ study will enroll 325 patients at 60 sites worldwide. The trial will assess device safety, pacing performance, AV-synchrony behavior, and quality-of-life outcomes to generate the evidence needed for global regulatory submissions.

“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 of 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.”

In April, the company earned U.S. Food and Drug Administration (FDA) approval for its Acticor Sky and Rivacor Sky implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) systems.