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Abbott (ABT) Gets FDA Approval for CardioMEMS HF System

·5 min read

Abbott Laboratories ABT recently gained FDA approval of an expanded indication for 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 in monitoring for signs of worsening heart failure.

The expanded indication will allow an additional 1.2 million patients in the United States to benefit from advanced monitoring with the CardioMEMS sensor, representing a significant increase over the current addressable population. The sensor acts as an early warning system for doctors, enabling them to treat worsening heart failure.

In 2014, the CardioMEMS HF System was first approved for use in New York Heart Association (NYHA) Class III heart failure patients who had been hospitalized for heart failure within the previous year. The new indication enables the CardioMEMS sensor to be utilized by Class II heart failure patients and those whose blood test show elevated levels of biomarkers known as natriuretic peptides, which is indicative of worsening heart failure.

Per Abbott’s management, this expanded indication will allow physicians to treat more patients with earlier-stage heart failure. This would present the opportunity to prevent further suffering and perhaps avoid later-stage progression, which can significantly impact a person's quality of life.

Background of the Approval

The CardioMEMS HF System's expanded indication was backed by clinical findings from the GUIDE-HF trial. Both Class II heart failure patients and patients with elevated natriuretic peptides were suggested to have better outcomes when their therapy was guided by pulmonary pressure monitoring, with a 34% and 25% reduction in heart failure hospitalizations, emergency visits, respectively, based on study data adjusted for the impact of COVID-19.

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Zacks Investment Research

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Benefits of CardioMEMS Monitoring

The CardioMEMS HF System can provide patients and their doctors with actionable insights that can help manage heart failure before it progresses to a later stage. The CardioMEMS sensor is a paperclip-sized device that monitors pressure changes suggesting worsening heart failure after being placed in the pulmonary artery during a minimally-invasive procedure. The sensor wirelessly transmits daily pressure readings to a patient's clinical team, allowing physicians to adjust therapy accordingly to prevent progression to late-stage heart failure. It also empowers patients to manage their condition from virtually anywhere.

Industry Prospects

Per a report published in GlobalData, the heart failure market is expected to see a CAGR of 19.5% by 2028 across the eight major markets of the United States, France, Germany, Italy, Spain, the U.K., Japan and China. The rising prevalence of chronic heart failure, the growing incidence of co-morbidities, and improved treatment and survival following myocardial infarction are driving the market.

Given the market prospects, the latest FDA approval of an expanded indication for the CardioMEMS HF System comes at an opportune time.

Other Notable Developments

Abbott has gained a number of regulatory approvals during January 2022.

The company announced the receipt of the 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.

The company received a new FDA approval with its Proclaim XR spinal cord stimulation system (SCS) for people with chronic pain. This time the regulatory body has approved an expanded magnetic resonance imaging compatibility for the Proclaim XR platform with Octrode leads. This approval will augment Abbott’s Neuromodulation arm, which is having a hard time amid the COVID-19 spell due to its elective nature of business.

Share Price Performance

The stock has outperformed its industry over the past year. It has declined 4.7% against the industry’s 19.5% growth.

Zacks Rank and Key Picks

Currently, Abbott carries a Zacks Rank #3 (Hold).

A few better-ranked stocks in the broader medical space are Henry Schein, Inc. HSIC, Owens & Minor, Inc. OMI and HealthEquity, Inc. HQY.

Henry Schein, currently carrying a Zacks Rank #1 (Strong Buy), has an estimated long-term growth rate of 11.8%. Henry Schein’s earnings surpassed estimates in the trailing four quarters, the average surprise being 25.5%. You can see the complete list of today’s Zacks #1 Rank stocks here.

Henry Schein has gained 26.5% compared with the industry’s 6.3% rise over the past year.

Owens & Minor, carrying a Zacks Rank #2 (Buy), has a long-term earnings growth rate of 23.6%. Owens & Minor’s earnings surpassed estimates in the trailing four quarters, delivering a surprise of 32.4%, on average.

Owens & Minor has outperformed the industry over the past year. OMI has gained 47.9% against the 19.5% industry decline in the said period.

HealthEquity, sporting a Zacks Rank #2, has a long-term earnings growth rate of 16.5%. HealthEquity’s earnings surpassed estimates in the trailing four quarters, delivering an average surprise of 9.8%.

HealthEquity has declined 34% compared with the industry’s 59.8% slump over the past year.

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