Abbott (ABT) Aveir VR Leadless Pacemaker Receives FDA Nod

Abbott Laboratories ABT recently announced the receipt of FDA approval for Aveir single-chamber (VR) leadless pacemaker to treat patients with slow heart rhythms in the United States. This represents a major advancement in patient care and brings new, never-before-seen features to patients and physicians.

This approval is supported by data from the global LEADLESS II phase 2 investigational device exemption (IDE) study presented at the annual Scientific Sessions of the Asia Pacific Heart Rhythm Society (APHRS) in November 2021. The study demonstrated that the device met its pre-specified primary endpoints.

The recent development is likely to fortify Abbott’s Cardiac Rhythm Management business.

About Aveir VR

Abbott's Aveir single chamber (VR) pacing system is the world's only leadless pacemaker with a unique mapping capability designed to enable physicians to measure electrical signals within the heart and determine the correct placement of the device before final implantation. The system has an increased projected battery life that lasts up to two times longer than other currently commercially available leadless pacemakers when using International Organization for Standardization (ISO) standard settings.

Additionally, Aveir VR is mainly designed to be retrieved when therapy needs to evolve or the device needs to be replaced. It can be implanted directly inside the heart's right ventricle via a minimally-invasive procedure to treat slower-than-normal heart rates.

Benefits of the Aveir VR System

Per Abbott management, the Aveir VR leadless pacemaker was intended to make the implantation and retrieval processes as seamless as possible for physicians and provide enhancement over existing options.

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The Aveir leadless pacemaker offers an exciting option for treating people with cardiac arrhythmias. In addition, Abbott's leadless pacemaker addresses the need for a single-chamber device that accommodates any therapy path for a patient through Aveir's retrieval capability and extended battery longevity.

Industry Prospects

Per a report by Persistence Market Research, the global leadless pacing systems market size was $29.4million in 2017 and is projected to see a CAGR of 10.0% by 2025.

The rise in the number of eligible patients, preference for new technology, growing geriatric population and rising number of cardiovascular diseases are driving the market.

Recent Developments

In February 2022, Abbott gained FDA approval for an expanded indication of its CardioMEMS HF System to support the care of heart failure patients. The CardioMEMS HF System has been found to reduce hospitalizations for patients with later-stage heart disease when utilized to monitor signs of worsening heart failure.

In January 2022, Abbott announced the receipt of FDA clearance for the EnSite X EP System with EnSite Omnipolar Technology (OT). The new system is available in the United States and across Europe and is intended to assist physicians in better treating abnormal heart rhythms, also known as cardiac arrhythmias.

Price Performance

Shares of the company have lost 0.9% in a year against the industry's fall of 15.3%.

Zacks Rank and Key Picks

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

Some better-ranked stocks in the broader medical space are McKesson Corporation MCK, AMN Healthcare Services, Inc. AMN and Bio-Rad Laboratories, Inc. BIO.

McKesson, carrying a Zacks Rank #2 (Buy), reported third-quarter fiscal 2022 adjusted earnings per share (EPS) of $6.15, which beat the Zacks Consensus Estimate of $5.38 by 14.3%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

McKesson has a long-term earnings growth rate of 11.8%. MCK has gained 59.7% compared with the industry’s 9.7% growth in the past year.

AMN Healthcare, flaunting a Zacks Rank #1, has a long-term earnings growth rate of 16.2%. The company surpassed earnings estimates in the trailing four quarters, delivering a surprise of 19.5%, on average.

AMN Healthcare has outperformed its industry in the past year. AMN has gained 39.3% versus the 54.3% industry decline.

Bio-Rad reported fourth-quarter 2021 adjusted EPS of $3.21, which surpassed the Zacks Consensus Estimate by 11.9%. It currently has a Zacks Rank #2.

Bio-Rad has an earnings yield of 2.3% versus the industry’s negative yield. BIO surpassed earnings estimates in the trailing four quarters, the average surprise being 66.9%.

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