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��«����Ƶ is leveling-up leadless pacemaker technology with its , which features increased battery longevity over current commercially available leadless pacemakers*¹ and the ability to be retrieved if therapy needs change in the future.

The minimally invasive device — implanted in the heart’s right ventricle to treat slower-than-normal heart rates — was recently approved by the U.S. Food and Drug Administration (FDA). This approval gives ��«����Ƶ a competitive boost in the  space, and reflects ��«����Ƶ’s continued push to develop leadless cardiac technology, which features a reduction in post-implant complications related to leads (flexible wires connecting the pacemaker to the heart).

In fact, the Aveir VR Leadless Pacemaker system is an important component of ��«����Ƶ’s broader leadless-pacing strategy. This strategy includes developing a dual-chamber leadless pacemaker — currently in  and not yet commercially available — designed for people who need both heart chambers paced at the same time.

Considering nearly 80% of people^2,3,4��who receive a pacemaker need a dual-chamber option and that there isn’t currently a leadless dual-chamber pacemaker on the market, ��«����Ƶ has strong potential to expand in the $1.5 billion U.S. pacing market.⁵

“Leadless pacing is a major pipeline program for ABT’s Rhythm Management division,” Cowen analysts wrote in a recent report. “We view Aveir’s approval as another example of ABT advancing its key growth drivers while navigating macro and micro challenges.”⁶

Aveir’s Competitive Advantage

FDA approval of the Aveir VR Leadless Pacemaker system was supported by data from the global , which evaluated the device in people with certain abnormal heart rhythms. The results showed the device met its pre-specified primary endpoints.

Setting ��«����Ƶ’s Aveir VR Leadless Pacemaker system apart are three critical, never-before-seen features in a leadless pacemaker:

• Unique mapping capability is designed to allow physicians to measure electrical signals within the heart and detect the correct placement of the device before final implantation.
• Increased battery life is projected to be up to two times longer than other commercially available leadless pacemakers when using the International Organization for Standardization settings.¹
• Designed to be retrieved⁷ if a person’s therapy needs evolve.

What’s Next?

��«����Ƶ is looking ahead to designing next-generation cardiac rhythm management technology that is expandable — focusing on enabling devices to be interchanged as different cardiac therapies are needed — and that is designed to communicate with one another inside the heart. The foundational innovations designed in the Aveir VR Leadless Pacemaker system provide the first step toward these future advancements.

“Our goal is to continue to build on the success of the Aveir VR Leadless Pacemaker to provide more first-of-their-kind products in the future, revolutionizing how abnormal heart rhythms are treated,” said Randel Woodgrift, senior vice president of Cardiac Rhythm Management at ��«����Ƶ.

Learn more about ��«����Ƶ’s  and its other .

*When using International Organization for Standardization (ISO) settings

References

¹International Organization for Standardization (ISO) VVIR settings: 2.5V@0.4ms, 600 Ω, 60 bpm, 100% pacing.

²Bernstein AD, Parsonnet V. Survey of cardiac pacing and defibrillation in the United States in 1993. American Journal of Cardiology. 1996;78(2):187. doi:10.1016/S0002-9149(96)90394-X.

³Acosta Velez JG, Amit G, Hernández Ruiz EA, Trusz-Gluza M, Leśniak W. Sinus Node Dysfunction. McMaster Textbook of Internal Medicine. Kraków: Medycyna Praktyczna.

. Accessed December 03, 2021.

⁴Hongo RH, Goldschlager NF. Chapter 14. Conduction Disorders & Cardiac Pacing. In: Crawford MH. eds. Current Diagnosis & Treatment: Cardiology, 4e. McGraw Hill; 2014. Accessed December 03, 2021. https://accessmedicine.mhmedical.com/content.aspx?bookid=715&sectionid=48214546 Reynolds D, Duray GZ, Omar R, et al. A Leadless Intracardiac Transcatheter Pacing System. The New England journal of medicine. 2016;374(6):533-541. doi:10.1056/NEJMoa1511643

⁵Data on file, ��«����Ƶ Investor Relations.

⁶Cowen, More Pipeline Progress, As Leadless Pacemaker Receives FDA Approval, April 4, 2022.

⁷The Aveir Retrieval Catheter is pending FDA 510k clearance and is not available for sale.