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Abiomed (ABMD) Posts Impellas Positive Study Results in Japan
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Abiomed, Inc. recently announced the result of a three-year, investigator-led study of all Impella-supported patients treated at 109 hospitals in Japan. The result shows a significant 30-day survival rate (77%) for patients with cardiogenic shock due to myocarditis (inflammation of the heart muscle often resulting from a viral infection).
The recent study, announced at the 2022 Transcatheter Cardiovascular Therapeutics conference in Boston, is an update to a 2020 interim analysis. The analysis studied 143 consecutive patients with cardiogenic shock due to myocarditis who received Impella support or Impella plus VA ECMO support, known as ECpella.
In August 2020, the FDA issued an emergency use authorization for left-sided Impella heart pumps to provide left ventricular unloading and support to COVID-19 patients undergoing ECMO treatment and developing pulmonary edema or myocarditis.
The latest multi-center, multi-society study of Impella-supported patients is a significant stepping stone for Abiomed’s coronary business across the world.
Significance of the Result
Per the U.S. Centers for Disease Control and Prevention’s report, the rate of occurrence of myocarditis has increased since the outbreak of the COVID-19 pandemic. The report also disclosed that patients with COVID-19 had a higher risk of developing myocarditis, unlike patients who did not have COVID-19.
Per the lead investigator of the recent study conducted in Japan, the findings further validate the potential of increasing native heart recovery in myocarditis patients via Impella, which is an important consideration given the limited number of heart transplants.
Industry Prospects
Per a report by Research and Markets, the global heart pump device market is anticipated to reach $5.5 billion by 2026 from $2.1 billion in 2021 at a CAGR of 21.6%. Factors like the rising prevalence of cardiovascular diseases and long waiting periods for heart transplants are likely to drive the market.
Given the market potential, the latest regulatory approvals are likely to provide a significant boost to Abiomed’s business globally.
Recent Developments
Abiomed, this month, announced the results of a three-year, investigator-led study of all Impella-supported patients treated at 109 hospitals in Japan. The study results, which are an update to a 2020 interim analysis, show 30-day survival rates of 81% for acute myocardial infarction cardiogenic shock (AMICS) patients.
The same month, Abiomed announced the results of a new per-protocol analysis of the ST-segment Elevation Myocardial Infarction Door-To-Unload pilot trial data. It shows significantly reduced infarct size in patients who received left ventricular (LV) unloading with Impella CP for 30 minutes prior to their PCI, unlike patients who received LV unloading followed by immediate PCI.
In September, Abiomed announced the receipt of two approvals from the FDA, which are related to clinical research of Impella heart pumps in AMICS patients. The first approval is for the on-label RECOVER IV randomized controlled trial for AMICS patients, while the second was for the RECOVER III post-approval study. The second has been approved and closed by the FDA.
Price Performance
Shares of the company have lost 25.8% in the past year compared with the industry’s 34.5% fall and the S&P 500's 13.6% decline.
Image Source: Zacks Investment Research
Zacks Rank & Key Picks
Currently, Abiomed carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are AMN Healthcare Services, Inc. (AMN - Free Report) , ShockWave Medical, Inc. and McKesson Corporation (MCK - Free Report) .
AMN Healthcare, flaunting a Zacks Rank #1 (Strong Buy) at present, has an estimated long-term growth rate of 3.2%. AMN’s earnings surpassed the Zacks Consensus Estimate in all the trailing four quarters, the average beat being 15.7%.
AMN Healthcare has lost 6.7% compared with the industry’s 38.1% fall in the past year.
ShockWave Medical, sporting a Zacks Rank #1 at present, has an estimated growth rate of 33.1% for 2023. SWAV’s earnings surpassed estimates in all the trailing four quarters, the average beat being 180.1%.
ShockWave Medical has gained 29.5% against the industry’s 34.5% fall over the past year.
McKesson, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 10.1%. MCK’s earnings surpassed estimates in three of the trailing four quarters and missed the same in one, the average beat being 13%.
McKesson has gained 70.5% against the industry’s 17.1% fall over the past year.
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Abiomed (ABMD) Posts Impellas Positive Study Results in Japan
Abiomed, Inc. recently announced the result of a three-year, investigator-led study of all Impella-supported patients treated at 109 hospitals in Japan. The result shows a significant 30-day survival rate (77%) for patients with cardiogenic shock due to myocarditis (inflammation of the heart muscle often resulting from a viral infection).
The recent study, announced at the 2022 Transcatheter Cardiovascular Therapeutics conference in Boston, is an update to a 2020 interim analysis. The analysis studied 143 consecutive patients with cardiogenic shock due to myocarditis who received Impella support or Impella plus VA ECMO support, known as ECpella.
In August 2020, the FDA issued an emergency use authorization for left-sided Impella heart pumps to provide left ventricular unloading and support to COVID-19 patients undergoing ECMO treatment and developing pulmonary edema or myocarditis.
The latest multi-center, multi-society study of Impella-supported patients is a significant stepping stone for Abiomed’s coronary business across the world.
Significance of the Result
Per the U.S. Centers for Disease Control and Prevention’s report, the rate of occurrence of myocarditis has increased since the outbreak of the COVID-19 pandemic. The report also disclosed that patients with COVID-19 had a higher risk of developing myocarditis, unlike patients who did not have COVID-19.
Per the lead investigator of the recent study conducted in Japan, the findings further validate the potential of increasing native heart recovery in myocarditis patients via Impella, which is an important consideration given the limited number of heart transplants.
Industry Prospects
Per a report by Research and Markets, the global heart pump device market is anticipated to reach $5.5 billion by 2026 from $2.1 billion in 2021 at a CAGR of 21.6%. Factors like the rising prevalence of cardiovascular diseases and long waiting periods for heart transplants are likely to drive the market.
Given the market potential, the latest regulatory approvals are likely to provide a significant boost to Abiomed’s business globally.
Recent Developments
Abiomed, this month, announced the results of a three-year, investigator-led study of all Impella-supported patients treated at 109 hospitals in Japan. The study results, which are an update to a 2020 interim analysis, show 30-day survival rates of 81% for acute myocardial infarction cardiogenic shock (AMICS) patients.
The same month, Abiomed announced the results of a new per-protocol analysis of the ST-segment Elevation Myocardial Infarction Door-To-Unload pilot trial data. It shows significantly reduced infarct size in patients who received left ventricular (LV) unloading with Impella CP for 30 minutes prior to their PCI, unlike patients who received LV unloading followed by immediate PCI.
In September, Abiomed announced the receipt of two approvals from the FDA, which are related to clinical research of Impella heart pumps in AMICS patients. The first approval is for the on-label RECOVER IV randomized controlled trial for AMICS patients, while the second was for the RECOVER III post-approval study. The second has been approved and closed by the FDA.
Price Performance
Shares of the company have lost 25.8% in the past year compared with the industry’s 34.5% fall and the S&P 500's 13.6% decline.
Image Source: Zacks Investment Research
Zacks Rank & Key Picks
Currently, Abiomed carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are AMN Healthcare Services, Inc. (AMN - Free Report) , ShockWave Medical, Inc. and McKesson Corporation (MCK - Free Report) .
AMN Healthcare, flaunting a Zacks Rank #1 (Strong Buy) at present, has an estimated long-term growth rate of 3.2%. AMN’s earnings surpassed the Zacks Consensus Estimate in all the trailing four quarters, the average beat being 15.7%.
You can see the complete list of today’s Zacks #1 Rank stocks here.
AMN Healthcare has lost 6.7% compared with the industry’s 38.1% fall in the past year.
ShockWave Medical, sporting a Zacks Rank #1 at present, has an estimated growth rate of 33.1% for 2023. SWAV’s earnings surpassed estimates in all the trailing four quarters, the average beat being 180.1%.
ShockWave Medical has gained 29.5% against the industry’s 34.5% fall over the past year.
McKesson, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 10.1%. MCK’s earnings surpassed estimates in three of the trailing four quarters and missed the same in one, the average beat being 13%.
McKesson has gained 70.5% against the industry’s 17.1% fall over the past year.