Abbott's (ABT) Heart Failure Device Study Outcome Favorable (Revised)
Based on the favorable outcome, Abbott (ABT) files a Premarket Approval (PMA) supplement with the FDA for consideration of an expanded indication for...
Abbott ABT recently released favorable data from its GUIDE-HF clinical trial on its small implantable pulmonary pressure sensor, CardioMEMS HF System. This landmark clinical trial is a 1,000 patient randomized study to evaluate the benefits of the CardioMEMS HF System in people living with New York Heart Association (NYHA) Class II, III and IV heart failure.
Meanwhile, NYHA’s functional classifications state that in case of Class II heart failure, ordinary physical activity results in fatigue, palpitation, and dyspnea (shortness of breath). In Class III cases, less than ordinary activity causes fatigue, palpitation, or dyspnea while in Class IV heart failure, discomfort increases if any physical activity is undertaken.
At present, CardioMEMS is approved for use in NYHA Class III patients who have had prior heart failure hospitalization within a year. The GUIDE-HF study examined patients with NYHA Class II and Class IV heart failure as well to evaluate the device in patients in earlier or later-stage disease progression.
The study results were presented at the ESC Congress 2021 and also were published in The Lancet. Based on the favorable outcome, Abbott has filed a Premarket Approval (PMA) supplement with the FDA for consideration of an expanded indication for the CardioMEMS device.
The Outcome at a Glance
Adjusting for the impact of COVID-19, the study data shows that in a broad range of patients, there has been a strong decline in the composite endpoint of heart failure hospitalizations, emergency visits and death. This reflects new benefits of the CardioMEMS device.
GUIDE-HF is one of Abbott’s many large trials that are being conducted amid the pandemic. During this period, due to health system disruption, heart failure patients who are at a heightened risk of COVID-19, experienced changes in care management and hospitalization. The full one-year data of GUIDE-HF on CardioMEMS HF System (of which 28% of the follow-up data was collected during COVID-19) showed that CardioMEMS-guided patients had a lower composite endpoint rate of total heart failure events and death compared to the study's control group. This was not statistically significant, Abbott stated.
Adjusting for the impact of COVID-19, CardioMEMS demonstrated a significant 19% reduction in the study's composite endpoint and a 28% reduction in heart failure hospitalizations.
The company is seeing significant opportunities in the cardiovascular space. According to Abbott, monitoring pulmonary arterial pressure is a great indicator for the prevention of acute heart failure and accordingly it has decided to invest in a larger trial to address the perceived shortcomings of the company’s previous CHAMPION study and augment the dataset.
Going by a Grand View Research report, the Congestive Heart Failure (CHF) treatment devices market was valued at $15.6 billion in 2015 and is expected to witness a CAGR of 8.1% from 2016 to 2024. The rising burden of Cardiovascular Diseases (CVDs) is one of the prime factors responsible for the growth of the CHF treatment devices market. Sedentary lifestyles, mental stress, and junk food consumption are other key factors associated with the development of CVDs.
In such a situation, the latest favorable outcome on CardioMEMS HF System seems to be well timed.
Zacks Rank and Key Picks
Currently, Abbott carries a Zacks Rank #3 (Hold).
A few better-ranked stocks from the broader medical space are Envista Holdings Corporation NVST, BellRing Brands, Inc. BRBR and Henry Schein, Inc. HSIC, each carrying a Zacks Rank #2 (Buy). You can see the complete list of Zacks #1 Rank (Strong Buy) stocks here.
Envista Holdings has an estimated long-term earnings growth rate of 27%.
BellRing Brands has an estimated long-term earnings growth rate of 29%.
Henry Schein has a projected long-term earnings growth rate of 14%.
(We are reissuing this article to correct a mistake. The original article, issued on August 30, 2021, should no longer be relied upon.)
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