Abbott Reveals State-of-the-Art Data Showing World's First Dual-Chamber Lead-Free Pacemaker Study Met All Three Primary Endpoints

Abbott’s AVEIR™ DR i2i™ IDE study is the industry’s first prospective study of the safety and performance of the world’s first dual-chamber leadless pacemaker.

The study successfully met all three primary safety and performance endpoints

Abbott’s AVEIR DR wireless pacemakers have been submitted for evaluation by the US FDA

NEW ORLEANS, May 20, 2023 /PRNewswire/ — Abbott (NYSE: ABT ) today announced the latest results from the i2i™ Investigational Device Exemption (IDE) AVEIR™ Dual Chamber (DR) study, a large-scale study to evaluate the first dual-chamber of the wireless pacemaker world, showing that the wireless pacemaker meets its three pre-specified primary endpoints for safety and performance. The data also suggest that AVEIR DR could offer new benefits for people with slower-than-normal heart rates.

World’s first study of dual-chamber lead-free pacing technology.

The results are being presented during a session of the latest clinical trials at the 44th Annual Meeting of the Heart Rhythm Society (HRS). in new orleans(May 19-21, 2023), and simultaneously published in The New England Journal of Medicine. The data has been provided to the US Food and Drug Administration (FDA) as part of Abbott’s submission for approval of the AVEIR DR device.

People who experience a slower than normal heart rate have traditionally been given a pacemaker, which is a small battery-operated device implanted under the skin in the chest. The device delivers electrical impulses directly to the heart muscle through thin insulated wires, known as cardiac leads, to restore a normal heart rhythm. Unlike traditional pacemakers, leadless pacemakers are implanted directly into the heart using a minimally invasive catheter-based procedure. This eliminates the need for heart leads and a pulse generator under the skin.

Although many people require pacing and sensing in both the right atrium and right ventricle, currently available leadless pacing options have been limited to single-chamber ventricular devices because the seamless and wireless synchronization of two wireless pacemakers has been a major technological challenge.

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“The vast majority of people who need a pacemaker require a dual-chamber pacemaker and would greatly benefit from a wireless device, but we’ve simply never had that option due to engineering challenges,” said Reinoud E. Knops, MD, Ph.D. ., professor of medicine at the Medical Center of the University of Amsterdam, Netherlands, and co-principal investigator of the AVEIR DR i2i IDE study. “The data from the AVEIR DR i2i study show that Abbott has designed an innovative technology for seamless communication between two wireless pacemakers and that AVEIR DR can safely deliver appropriate therapy, opening a future treatment option for more people with abnormal heart rhythms.”

Abbott designed the AVEIR DR pacemaker (the DR stands for dual-chamber rate response) with first-of-its-kind i2i (implant-to-implant) technology, with the goal of providing beat-to-beat communication and synchrony between two wireless pacemakers, a necessary foundation of dual-chamber wireless pacing therapy. Unlike other wireless pacemakers, this system allows the two devices to communicate with each other, detecting a delayed or missed heartbeat and then pacing the appropriate heart chamber.

In addition, Abbott’s AVEIR leadless devices use specially designed attachment mechanisms that allow pacemakers to be retrieved when changes in therapy are needed. In the AVEIR DR i2i IDE study, doctors successfully implanted leadless pacemakers in the right atrium along with a leadless device implanted in the right ventricle for the first time.

State-of-the-art data from the AVEIR DR i2i IDE study
Under the AVEIR DR i2i IDE study, the main safety and efficacy criteria were analyzed in the first 300 people enrolled in 55 centers of the united states, canada and Europe. AVEIR DR1 design goals include technologies to regulate heart rate synchronously and continuously between both chambers enabling true dual-chamber wireless pacing.

The results of the AVEIR DR i2i IDE study three months after implantation showed:

Doctors demonstrated a 98.3% implant success rate.

The safety endpoint assessing freedom from device or procedural complications was achieved.

More than 97% of people had successful atrioventricular (AV) synchrony, so that the upper and lower chambers beat normally, despite different types of underlying slow heart rhythms.

Average AV synchrony was greater than 95% in each of seven different walking postures and speeds, demonstrating that the system will perform adequately during activities of daily living.

“For the first time, the AVEIR DR i2i study has shown that a dual-chamber wireless stimulation device is not only possible, but can meet the rigors of everyday stimulation therapy needs,” he said. Randall Woodgrift, senior vice president of Abbott’s cardiac rhythm management business. “The results of the AVEIR DR study are a strong indication that dual-chamber AVEIR pacemakers may offer new options for clinicians to treat a broader group of people who require pacemaker therapies.”

About the AVEIR DR i2i IDE study
The goal of the AVEIR DR i2i IDE study is to show that the AVEIR DR pacemaker is safe and effective for people who experience a slower than normal or irregular heart rate and can receive a dual-chamber pacemaker to help restore a rhythm more normal heart rate The AVEIR DR i2i IDE study is a prospective, multicenter, international, single-arm, pivotal research study.

Behind the AVEIR technology
Smaller than a AAA battery, the AVEIR Cordless Pacemaker is implanted using a minimally invasive procedure, the device is attached to the inner wall of the heart with a screw mechanism, known as a helix, which allows the cordless pacemaker to be retrieved if therapy is needed. evolve or if the device needs to be replaced in the future. Wireless ventricular and atrial devices are also designed to provide real-time mapping capability so that clinicians can assess proper device placement prior to implantation. The new i2i communication technology provides a synchronized or coordinated heart rhythm between two wireless pacemakers based on the person’s rhythm-to-rhythm clinical needs. The AVEIR system is modular, so a single device can be implanted in one heart chamber initially, and the second pacemaker added to the other heart chamber in the future if the clinical need arises. AVEIR wireless pacemakers are designed for recovery, should therapy need to change in the future. Device design specifications are subject to change pending regulatory review.

About Abbott
Abbott is a global healthcare leader helping people live more fully at every stage of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading companies and products in diagnostics, medical devices, nutritionals and branded generics. Our 115,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.comon LinkedIn at www.linkedin.com/company/abbott-/on Facebook at http://www.facebook.com/Abbott and on Twitter @AbbottNews.

1 AVEIR DR design goals are subject to change pending FDA review.