First US patient implanted with Biotronik leadless pacemaker
The first U.S. implant of Biotronik's LivIQ leadless pacemaker was performed as part of the BIO-LivIQ global pivotal trial. The company said this offers a single-device solution designed to deliver atrioventricular (AV) synchrony through advanced electrical atrial far-field sensing.
“Our team is pleased to be the first to implant the LivIQ device in the United States,” James Ip, MD, FACC, FHRS, director of cardiac pacing and implantable devices and principal investigator at Weill Cornell Medicine, said in a statement. “This novel leadless pacemaker that is designed to provide AV synchronous pacing using a single device could potentially advance the field of leadless pacing.”
This is Biotronik's entry into the leadless pacing system space, which has seen rapid growth over the past few years because it eliminates the need for creating a surgical pocket to implant a larger, traditional pacemaker, and it eliminated the need to place lead wired through the vascular system.
The device uses far-field sensing to detect atrial activity and enable a single device VDD mode. This new sensing approach supports AV synchrony across a broad range of clinical presentations. The device also features a highly maneuverable catheter to make it easier to place.
The company said it developed the technology to address gaps in current leadless technologies. This includes a single leadless device that has intuitive catheter handling with AV synchrony, even when the patient has an elevated heart rate and when higher cardiac output is required.
The BIO-LivIQ study will enroll 325 patients across 60 centers worldwide. The trial will look at safety, pacing efficacy, AV-synchrony behavior and patient quality-of-life outcomes data that will be used for global regulatory submissions.
The LivIQ is an investigational device and limited to investigational use in this trial.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]