ABT Abbott Laboratories

• Abbott's AVEIR™ DR leadless pacemaker system was first implanted at the Montreal Heart Institute in Montreal, Quebec and Foothills Medical Centre in Calgary, Alberta
• The AVEIR DR leadless pacemaker system is designed to address abnormal heart rhythms ¹
• Abbott's first-of-its-kind i2i™ technology enables synchronized communication between two leadless pacemakers, which are each roughly one-tenth the size of a traditional pacemaker¹

MONTREAL, Aug. 15, 2024 /CNW/ -- Abbott (NYSE: ABT) today announced that the AVEIR™ dual chamber (DR) leadless pacemaker system, the world's first dual chamber leadless pacemaker system that treats people with abnormal or slow heart rhythms,¹ has been implanted for the first time at the Montreal Heart Institute, in Montreal, Quebec and Foothills Medical Centre in Calgary, Alberta.

The AVEIR DR leadless pacemaker system is a significant innovation that enables beat-to-beat, wireless communication between two leadless pacemakers¹, designed to address the needs of people living with abnormal heart rhythms and expand treatment options in Canada.

Heart rhythm disorders occur in approximately 2% of the population.² As of 2023, more than 200,000 Canadians live with a pacemaker, which helps regulate a patient's heartbeat, including those with bradycardia - a condition where the heart beats too slowly.³  

The AVEIR DR leadless pacemaker system uses a new method of delivering dual chamber therapy as it is comprised of two unique devices – one that paces the right atrium (AVEIR AR). And one that paces the right ventricle (AVEIR VR). Each device is roughly one-tenth the size of a traditional pacemaker.¹

A traditional pacemaker is a battery-powered device implanted underneath the skin in the chest through a surgical procedure. The device delivers electrical therapy to the heart via thin insulated wires known as cardiac leads, and often leaves a chest scar and device bulge that is visible. Unlike traditional pacemakers, leadless devices are implanted directly into the heart through a minimally invasive procedure, eliminating cardiac leads. As a result, leadless pacemakers reduce people's exposure to potential lead- and infection-related complications and offer a less restrictive and shorter recovery period post-implantation.¹

Dr. Blandine Mondésert, cardiologist from Montreal Heart Institute and Dr. Derek Exner, a Calgary-based heart-rhythm specialist, were the first physicians to perform the implants in Canada.

"The availability of this innovative technology is momentous for cardiac patients in Quebec and across Canada," said Dr. Mondésert. "Reducing short and long-term lead-related complications associated with traditional pacemakers has been our goal as physicians. Now with the new Abbott AVEIR DR system, as physicians, we have the capacity to address abnormal heart rhythms, while reducing complications and improving patient outcomes. It's going to become a game changer in our practice."

"The AVEIR DR system is a significant advancement, as physicians can now provide a treatment option for Canadians that is less invasive," said Dr. Exner. "Unlike traditional pacemakers, this system improves comfort, reduces long-term risk, and improves quality of life. These devices are out of sight and out of mind. They allow patients to focus on their health, not their disease."

Through Abbott's proprietary i2i™ (implant-to-implant) communication technology, AVEIR DR provides synchronized pacing between two leadless pacemakers on every heartbeat based on a person's clinical needs. The i2i technology uses high-frequency pulses to relay messages via the naturally conductive characteristics of the body's blood between the paired, co-implanted devices. Conductive communication uses far less battery current than inductive, radio-frequency or Bluetooth^®* communication, alternatives often used in traditional pacemakers. ¹

"Since its inception, pacemaker technology has remained fundamentally unchanged as seamless synchronization of two leadless pacemakers has been a significant challenge – one that Abbott engineers sought to solve," said Leonard Ganz, M.D., divisional vice president of medical affairs and chief medical officer at Abbott's cardiac rhythm management business. "AVEIR DR addresses a critical need for people living with slow and abnormal heart rhythms and enhances people's quality of life with its revolutionary leadless design."

The AVEIR DR i2i Global Clinical Investigation study showed that AVEIR DR met its one-year prespecified primary endpoints for safety and efficacy, demonstrating consistent outcomes through 12-month follow-up.⁴ Results through one-year post-implant showed a 98.3% system implant success rate. More than 97% of people had a successful atrio-ventricular synchrony, so that the upper and lower chambers were beating normally, despite different postures and gaits.⁵

For important safety information on the AVEIR DR leadless pacemaker system, visit: https://manuals.eifu.abbott/en/index.html

About Abbott:
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com and on LinkedIn, Facebook, Instagram, X and YouTube.

*Bluetooth is a registered trademark of Bluetooth SIG, Inc.

¹ AVEIR Leadless Pacemakers and Delivery Catheter IFU. ARTEN600306569
² Sridhar A, et al., Eds. Cardiac arrhythmias. Nature. 2023. https://www.nature.com/collections/ccghcjejeh
³ Fairbairn B. Calgary cardiologist leads pacemaker revolution. Alberta Health Services. February 6, 2023.
⁴ R. Knops et al. One year safety and performance outcomes from a clinical study of a dual-chamber leadless pacemaker system. Presented at HRS 2024; May 18, 2024, Boston, USA.
⁵ Daniel J. Cantillon, Srinivas R. Dukkipati, et al. Comparative study of acute and mid-term complications with leadless and transvenous cardiac pacemakers. Heart Rhythm, Volume 15, Issue 7, 2018, Pages 1023-1030, ISSN 1547-5271, https://doi.org/10.1016/j.hrthm.2018.04.022 Knops RE, Reddy VY, Ip JE, et al. A

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MAT-2409210 v1.0 |   Item approved for Canada use only.

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