Sam Brusco, Associate Editor05.23.23
Abbott Labs released late-breaking results from its Aveir dual-chamber (DR) i2i investigational device exemption (IDE) study, a large-scale study to evaluate the dual-chamber leadless pacemaker.
The results showed Aveir DR met its three primary endpoints for safety and performance. The data further suggests Aveir DR could provide new benefits for patients with slower-than-normal heart rhythms. The results were published in The New England Journal of Medicine and has been provided to the U.S. Food and Drug Administration (FDA) as part of Abbott’s submission for approval.
Unlike traditional pacemakers, leadless pacemakers are implanted directly into the heart via a minimally invasive, catheter-based procedure. This removes the need for cardiac leads and a pulse generator under the skin. Current leadless pacing options have been limited to single-chamber ventricular devices because seamless, wireless synchronization of two leadless pacemakers has been a technological challenge.
"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," Reinoud E. Knops, MD, Ph.D., professor of medicine, Amsterdam University Medical Center, Netherlands, and co-principal investigator of the AVEIR DR i2i IDE study, told the press. "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."
Abbott’s i2i implant tech in Aveir DR has a goal of beat-to-beat communication and synchrony between two leadless pacemakers. The system allows communication between the two devices: sensing for delayed or missed heartbeat, and then pacing the appropriate heart chamber. Further, the devices use attachment mechanisms for retrieving the pacemakers when changes in therapy are needed. In the Aveir DR i2i IDE study, physicians successfully implanted leadless pacemakers in the right atrium with another leadless device implanted in the right ventricle.
After three-months post-implant, physicians showed a 98.3% implant success rate. Over 97% of people had successful atrio-ventricular (AV) synchrony so the upper and lower chambers were beating normally, despite different types of underlying slow heart rhythms. Average AV synchrony was over 95% in each of seven different posture and walking speeds, showing the system will function appropriately during everyday activities.
"For the first time, the AVEIR DR i2i study has shown that a dual-chamber leadless pacing device is not only possible but can meet the rigors of everyday needs of pacing therapy," said Randel Woodgrift, senior vice president of Abbott's cardiac rhythm management business. "The results of the AVEIR DR study are a strong indicator that the AVEIR dual-chamber pacemakers can offer new options so that physicians can treat a broader group of people that need pacemaker therapies. "
The results showed Aveir DR met its three primary endpoints for safety and performance. The data further suggests Aveir DR could provide new benefits for patients with slower-than-normal heart rhythms. The results were published in The New England Journal of Medicine and has been provided to the U.S. Food and Drug Administration (FDA) as part of Abbott’s submission for approval.
Unlike traditional pacemakers, leadless pacemakers are implanted directly into the heart via a minimally invasive, catheter-based procedure. This removes the need for cardiac leads and a pulse generator under the skin. Current leadless pacing options have been limited to single-chamber ventricular devices because seamless, wireless synchronization of two leadless pacemakers has been a technological challenge.
"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," Reinoud E. Knops, MD, Ph.D., professor of medicine, Amsterdam University Medical Center, Netherlands, and co-principal investigator of the AVEIR DR i2i IDE study, told the press. "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."
Abbott’s i2i implant tech in Aveir DR has a goal of beat-to-beat communication and synchrony between two leadless pacemakers. The system allows communication between the two devices: sensing for delayed or missed heartbeat, and then pacing the appropriate heart chamber. Further, the devices use attachment mechanisms for retrieving the pacemakers when changes in therapy are needed. In the Aveir DR i2i IDE study, physicians successfully implanted leadless pacemakers in the right atrium with another leadless device implanted in the right ventricle.
Aveir DR i2i IDE Study Late-Breaking Data
The primary safety and efficacy endpoints were analyzed in the first 300 people enrolled in 55 centers in the U.S., Canada, and Europe.After three-months post-implant, physicians showed a 98.3% implant success rate. Over 97% of people had successful atrio-ventricular (AV) synchrony so the upper and lower chambers were beating normally, despite different types of underlying slow heart rhythms. Average AV synchrony was over 95% in each of seven different posture and walking speeds, showing the system will function appropriately during everyday activities.
"For the first time, the AVEIR DR i2i study has shown that a dual-chamber leadless pacing device is not only possible but can meet the rigors of everyday needs of pacing therapy," said Randel Woodgrift, senior vice president of Abbott's cardiac rhythm management business. "The results of the AVEIR DR study are a strong indicator that the AVEIR dual-chamber pacemakers can offer new options so that physicians can treat a broader group of people that need pacemaker therapies. "
