Abbott's (ABT) AVEIR DR Leadless Pacemaker System Gains CE Mark

Abbott ABT recently received a CE Mark in Europe for the AVEIR dual chamber (DR) leadless pacemaker system, the first ever dual chamber leadless pacemaker that treats people with abnormal or slow heart rhythms. The news follows the system’s FDA approval in June last year, shortly after late-breaking clinical data revealed that the AVEIR DR system met its three prespecified primary endpoints for safety and efficacy.

The latest development is expected to significantly boost the company’s Cardiac Rhythm Management business under the Medical Devices segment.

Significance of the AVEIR DR System

A traditional pacemaker is a small 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, better 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.

Abbott’s breakthrough innovation enables the world's first beat-to-beat, wireless communication between two leadless pacemakers. The AVEIR DR system utilizes a new method of delivering dual-chamber therapy as it is comprised of two unique devices, one that paces the right ventricle (AVEIR VR) and one that paces the right atrium (AVEIR AR). Each device is roughly one-tenth the size of a traditional pacemaker and smaller than a AAA battery.

 

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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 utilizes 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, which are alternatives often used in implantable medical devices or traditional pacemakers.

More on the News

Pacemaker technology has remained fundamentally unchanged since its inception, as seamless synchronization of two leadless pacemakers has been a significant challenge. The AVEIR DR addresses a critical need for people living with slow heart rhythms, enhancing their quality of life with its breakthrough leadless design. With approximately 49 million people living with cardiovascular disease in the European Union andan estimated 14.4 million people aged 65 and older likely to have atrial fibrillation by 2060, the AVEIR DR system expands treatment options in Europe.

The AVEIR DR i2i Global Clinical Investigation study showed that AVEIR DR met its three prespecified primary endpoints for safety and efficacy. Results through three months post-implant showed a 98.3% system implant success rate and 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.

Industry Prospects

Per a Research report, the global leadless pacemakers market was valued at $514.9 million (estimated) in 2022 and is expected to witness a CAGR of 15.7% by 2030.

The market is expected to grow due to several factors, such as the growing geriatric population susceptible to cardiovascular diseases, increasing incidence of bradyarrhythmia, growing product approvals in developed countries, lucrative product pipeline for leadless pacemakers, and its benefits over the traditional pacemakers.

Notable Developments in the Cardiac Rhythm Management Business

In March 2024, Abbott gained CE Mark approval for the Assert-IQ insertable cardiac monitor (ICM), the newest addition to the company’s growing portfolio of connected health devices. The offering provides physicians with a new option for diagnostic evaluation and long-term monitoring of people experiencing abnormal heartbeats. Notably, Assert-IQ is claimed to offer the world's longest battery life for a Bluetooth enabled ICM.

Price Performance

In the past year, ABT shares have increased 3.9% in line with the industry’s rise of 3.9%.

Zacks Rank and Key Picks

Abbott currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space are Hims & Hers Health HIMS, Medpace MEDP and ResMed RMD. While Hims & Hers Health and Medpace each sport a Zacks Rank #1 (Strong Buy), ResMed carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks Rank #1 stocks here.

Hims & Hers Heath stock has surged 143.8% in the past year. Estimates for the company’s earnings have remained constant at 18 cents in 2024 and increased 3.1% to 33 cents in 2025 in the past 30 days.

HIMS’ earnings beat estimates in three of the trailing four quarters and missed in one, delivering an average surprise of 79.2%. In the last reported quarter, it posted an earnings surprise of a staggering 150%.

Estimates for Medpace’s 2024 earnings per share have moved up to $11.29 from $11.23 in the past 30 days. Shares of the company have surged 81.4% in the past year compared with the industry’s 4.2% growth.

MEDP’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 12.8%. In the last reported quarter, it delivered an average earnings surprise of 30.6%.

Estimates for ResMed’s fiscal 2024 earnings per share have remained constant at $7.70 in the past 30 days. Shares of the company have declined 2.1% in the past year against the industry’s growth of 3.9%.

RMD’s earnings surpassed estimates in three of the trailing four quarters and missed in one, the average surprise being 2.8%. In the last reported quarter, it delivered an earnings surprise of 10.9%.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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