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Abiomed (ABMD) Reports Positive Data Backing preCARDIA System

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Abiomed recently announced favorable results from the first-in-human early feasibility study of the preCARDIA system. The study findings were published in the journal titled: “Circulation: Heart Failure.”

Per company-provided data, heart failure is the primary cause of hospitalization in patients aged above 65 years despite available pharmaceutical treatments. While diuretics can help improve heart failure symptoms and heart function, they take time to work and may be ineffective in chronic heart failure patients.

By intermittently occluding the superior vena cava, the preCARDIA system is aimed at improving decongestion in patients with acutely decompensated heart failure (ADHF).

This announcement is likely to further boost Abiomed's extensive product portfolio.

Few Words About preCARDIA

The preCARDIA system is intended to lower filling pressure as blood enters the heart and lungs, allowing the heart and kidneys to work more effectively. It can be used to provide treatment for patients who are non-responsive to diuretics, which account for approximately 300,000 of the 1 million ADHF admissions in the United States each year.

More on the Study Results

The VENUS-HF Early Feasibility Study — a multicenter, prospective, single-arm study — assessed 30 patients with ADHF who were given preCARDIA treatment for 12 or 24 hours. The study met its safety and feasibility endpoints, indicating for the first time that the preCARDIA system can be used to rapidly reduce cardiac filling pressures and increase urine output in ADHF patients by intermittently occluding the superior vena cava.

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In the study, 100% of patients did not exhibit any device- or procedure-related major adverse events and 97% of patients had a successful placement, activation, and removal of preCARDIA.

The findings of the VENUS-HF Early Feasibility Study support further research of preCARDIA. The FDA approved the expansion of preCARDIA’s early feasibility study by 30 additional patients to a total of 60 patients in November 2021. The preCARDIA is limited to being used for investigational purposes under federal legislation.

Industry Prospects

Per a report published in GlobalData, the heart failure (HF) market is anticipated to witness a CAGR of 19.5% across eight major markets comprising the United States, France, Germany, Italy, Spain, the U.K., Japan and China by 2028. Factors such increasing prevalence of chronic HF, given a surge in the aging population and the growing incidence of co-morbidities, are among the major market drivers.

Notable Developments

In January 2022, Abiomed gained regulatory approval for Impella surgical products in three countries. The Impella BTR (Bridge-to-Recovery) has received an Early Feasibility Study Investigational Device Exemption from the FDA in the United States. Meanwhile, the Impella 5.5 with SmartAssist has been approved by both the Pharmaceuticals and Medical Devices Agency of Japan and the Medical Device Division of Hong Kong.

In November 2021, the company presented the final results of PROTECT III and Restore EF prospective studies, which demonstrated that the use of Impella heart pumps improves outcomes for high-risk percutaneous coronary intervention (PCI) patients. The current data from these prospective studies testify that implementing Impella best practices enhances safety, while reducing major adverse cardiovascular events in high-risk PCI patients.

Share Price Performance

The stock has declined 13.1%, underperforming the industry’s 4.8% fall over the past year.

Zacks Rank and Key Picks

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

Some better-ranked stocks in the broader medical space include Baxter International Inc. (BAX - Free Report) , Hologic, Inc. (HOLX - Free Report) and Apollo Endosurgery, Inc. .

Baxter, currently carrying a Zacks Rank #1 (Strong Buy), has a long-term earnings growth rate of 9.5%. Baxter’s earnings surpassed estimates in the trailing four quarters, delivering a surprise of 10.2%, on average. You can see the complete list of today’s Zacks #1 Rank stocks here.

Baxter has outperformed the industry over the past year. BAX has gained 7.9% against a 12.8% decline of the industry in the said period.

Hologic, carrying a Zacks Rank #1 at present, has a long-term earnings growth rate of 7.4%. The company surpassed earnings estimates in three of the trailing four quarters and missed on another occasion, delivering an average surprise of 29.2%.

Hologic has declined 10.1%, underperforming the industry’s 6.1% drop over the past year.

Apollo Endosurgery, presently carrying a Zacks Rank #2 (Buy), has a long-term earnings growth rate of 7%. Apollo Endosurgery’s earnings surpassed estimates in the trailing four quarters, delivering a surprise of 25.6%, on average.

Apollo Endosurgery has outperformed the industry in the past year. APEN has gained 43.5% versus the industry’s 6.1% fall in the said period.

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