Abbott has unveiled positive late-breaking results from a study (NCT05252702) investigating the safety and performance of its new dual-chamber leadless pacemaker in patients with heart conditions that require a dual-chamber rate-modulated (DDDR) pacemaker.
In the data announced by Abbott at the Heart Rhythm Society (HRS) 2023 meeting, “97% of people had successful atrioventricular (AV) synchrony, so that the upper and lower chambers were beating normally, despite different types of underlying slow heart rhythms.”
In addition to a 98% implant success rate and safety endpoints being met, the AV synchrony was also mostly maintained in different postures indicating functionality during everyday activities. Primary safety and efficacy endpoints were analysed in the first 300 people enrolled across 55 centers in the US, Canada, and Europe.
Unlike traditional pacemakers, which require thin insulated wires, leadless pacemakers are implanted directly into the heart’s interior wall. Many people require assistance in the right atrium and the right ventricle and Abbott says they have developed the first device that is both leadless and dual chamber responding.
Abbott’s system, called Aveir DR, uses implant-to-implant technology which allows two devices across two chambers to communicate with each other. Because the devices are separate, one pacemaker can be added initially, and the second later if the clinical requirement arises.
This modular approach gives the system a distinct flexibility for heart rhythm management. Moreover, a screw-in mechanism means that the pacemakers can be retrieved when changes in therapy are needed.
In April 2022, the US Food and Drug Administration (FDA) approved the Aveir VR system for single-chamber use. Abbott says it has submitted the dual-chamber pacemaker to the FDA for evaluation.
According to a market report by GlobalData, the pacemaker market is predicted to be worth $7.3bn by 2030, with dual-chamber pacemakers estimated to constitute $6.2bn.
“The vast majority of people needing a pacemaker require a dual-chamber pacemaker and would greatly benefit from a leadless device – but we’ve simply never had that option due to engineering challenges,” said Reinoud E. Knops, M.D., Ph.D., professor of medicine, Amsterdam University Medical Center, Netherlands, and co-principal investigator of the AVEIR DR i2i IDE study.
“Data from the AVEIR DR i2i study show that Abbott has designed a groundbreaking technology for seamless communication between two leadless pacemakers, and that AVEIR DR can deliver appropriate therapy safely, opening up a future treatment option for more people with abnormal heart rhythms.”