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Abbott (ABT) Unveils Late-Breaking Data on Leadless Pacemaker

Abbott ABT announced a favorable outcome on its leadless pacemaker. The company unveiled late-breaking results from the AVEIR dual-chamber (DR) i2i Investigational Device Exemption (IDE) study.

The study demonstrated that AVEIR DR leadless pacemaker met its three prespecified primary endpoints for safety and performance. The data also noted that this device could provide new benefits for people with slower-than-normal heart rhythms.

This favorable outcome has been sent to the FDA as part of Abbott's submission for approval of the AVEIR DR device.

More on the News

The results were presented during a late-breaking clinical trial session at the Heart Rhythm Society's (HRS) 44th annual meeting from May 19-21, 2023. The study has also been published in The New England Journal of Medicine.

Abbott noted that in the study, primary safety and efficacy endpoints were analyzed in the first 300 people enrolled across 55 centers in the United States, Canada and Europe.  Its three-month post-implant results showed that physicians demonstrated a 98.3% implant success rate. Further, the safety endpoint evaluating freedom from device or procedure complications was achieved. The company also noted that more than 97% of people had successful atrio-ventricular (AV) synchrony.

Added to this, in each of the seven different postures and walking speeds, the average AV synchrony was more than 95%. This, according to Abbott, implies that the system will function appropriately during everyday life activities.


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Zacks Investment Research

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Here's How AVEIR DR is Better

According to Abbott, unlike traditional pacemakers, leadless pacemakers are implanted directly into the heart through a minimally invasive, catheter-based procedure. This eliminates the need for cardiac leads and a pulse generator under the skin.

The company stated that many people require pacing and sensing in both the right atrium and the right ventricle. However, the currently available leadless pacing options are limited to single-chamber ventricular devices. This is because seamless, wireless synchronization of two leadless pacemakers has been a significant technological challenge.

For the vast majority of people, a dual-chamber pacemaker like AVEIR DR will be of great benefit.

Industry Prospects

Per a report by Grand View Research, the global arrhythmia monitoring devices market size is expected to reach $8.41 billion in 2025, with a CAGR of 6.8%. Continuous R&D activities in the field of cardiac monitoring are driving the market.

Latest Development

Abbott’s last-reported first quarter of 2023 organic sales, excluding COVID testing, increased 10%, led by double-digit growth in Medical Devices, Established Pharmaceuticals Division (EPD) and Nutrition. Within EPD, sales increased 11% in the quarter led by strong performance in Brazil, China, and Southeast Asia and across several therapeutic areas, including cardiometabolic, gastroenterology, CNS and pain management.

Within Nutrition, sales increased more than 10%. In the United States, pediatric nutrition growth of more than 35% was driven by favorable year-over-year comparisons (lower sales in the first quarter of 2022 were due to a voluntary recall of certain infant formula products).

Within Diagnostics, excluding COVID testing, organic sales growth was led by mid-to-high single-digit growth in Core Lab, Rapid and Point of Care Diagnostics. Despite dull sales in China, Core Lab Diagnostics sales showed year-over-year improvement, driven by strong performance in the United States and Europe.

Within Medical Devices, sales grew 12.5% globally on an organic basis, including mid-teens growth in the United States and double-digit growth internationally. In Diabetes Care, sales of FreeStyle Libre grew more than 25% on an organic basis in the quarter, including approximately 50% growth in the United States and mid-teens growth internationally.

Share Price Performance

Over the past year, Abbott has been outperforming the industry it belongs to. The stock has lost 5.3% compared with the industry’s 29.6% fall.

Zacks Rank & Key Picks

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

Some better-ranked stocks in the broader medical space are Zimmer Biomet ZBH, Penumbra PEN and Hologic, Inc. HOLX.

Zimmer Biomet, sporting a Zacks Rank #1 (Strong Buy) at present, has an earnings yield of 5.42% compared to the industry’s -1.86%. Zimmer Biomet’s earnings surpassed the Zacks Consensus Estimate in all the trailing four quarters, the average surprise being 7.38%.

You can see the complete list of today’s Zacks #1 Rank stocks here.

Zimmer Biomet shares have risen 11.9% against the industry’s 29.6% decline in the past year.

Penumbra, sporting a Zacks Rank #1 at present, has an estimated growth rate of 64.1% for 2024. Penumbra shares have risen 123.7% compared with the industry’s 2.3% increase over the past year.

PEN’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 109.4%.

Hologic, carrying a Zacks Rank #2 (Buy) at present, has an earnings yield of 4.68% compared to the industry’s -7.62%. Shares of HOLX have risen 3.6% compared with the industry’s 2.4% growth over the past year.

Hologic’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 27.3%.

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