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Abiomed's (ABMD) Impella-Related Research Gets FDA Clearance
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Abiomed, Inc. recently announced the receipt of two approvals from the FDA, which are related to clinical research of Impella heart pumps in acute myocardial infarction (AMI) cardiogenic shock patients. The first approval is for the on-label RECOVER IV randomized controlled trial (RCT) for AMI cardiogenic shock patients, while the second was for the RECOVER III post-approval study (PAS). The second has been approved and closed by the FDA.
The RECOVER IV is a two-arm trial expected to assess whether the percutaneous coronary intervention (PCI), with Impella support initiated prior to the PCI, is superior to PCI without Impella support.
The latest regulatory clearances for clinical research of Impella heart pumps in AMI cardiogenic shock patients are significant stepping stones for Abiomed’s coronary business across the world.
Significance of the Approval
Per an expert associated with the RECOVER IV RCT, the trial will likely apply the clinical advancements made thus far to improve the survival rate and heart recovery for AMI patients with cardiogenic shock, as indicated in multiple prospective studies.
Apart from meeting the primary and secondary endpoints of RECOVER IV RCT, Abiomed’s aim in conducting the trial is to achieve a global AMI cardiogenic shock Class I guideline recommendation for Impella and related best practice protocols, including Impella implantation pre-PCI.
The RECOVER III PAS has gathered real-world evidence on AMI cardiogenic shock patients treated with Impella, thus fulfilling Abiomed’s PAS requirement. The FDA’s approval and closure of RECOVER III further validate Impella as a safe and effective therapy for AMI cardiogenic shock.
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 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.
The same month, Abiomed announced that it will highlight how Impella heart pumps help heart teams achieve complete high-risk revascularization and heart recovery in the catheterization lab and operating room at the currently ongoing Transcatheter Cardiovascular Therapeutics 2022 Conference being held in Boston.
Last month, Abiomed announced favorable results from the Restore EF study, which was published online the same month in JSCAI. The result demonstrated that Impella-supported high-risk PCI leads to significant improvements in left ventricular ejection fraction, angina symptoms and heart failure symptoms at follow-up.
Price Performance
Shares of the company have lost 25.5% in the past year compared with the industry’s 31.5% fall and the S&P 500's 12.4% 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. (SWAV - Free Report) 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 4.3% compared with the industry’s 35.9% 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 33.4% against the industry’s 31.5% 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 71.5% against the industry’s 15% fall over the past year.
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Abiomed's (ABMD) Impella-Related Research Gets FDA Clearance
Abiomed, Inc. recently announced the receipt of two approvals from the FDA, which are related to clinical research of Impella heart pumps in acute myocardial infarction (AMI) cardiogenic shock patients. The first approval is for the on-label RECOVER IV randomized controlled trial (RCT) for AMI cardiogenic shock patients, while the second was for the RECOVER III post-approval study (PAS). The second has been approved and closed by the FDA.
The RECOVER IV is a two-arm trial expected to assess whether the percutaneous coronary intervention (PCI), with Impella support initiated prior to the PCI, is superior to PCI without Impella support.
The latest regulatory clearances for clinical research of Impella heart pumps in AMI cardiogenic shock patients are significant stepping stones for Abiomed’s coronary business across the world.
Significance of the Approval
Per an expert associated with the RECOVER IV RCT, the trial will likely apply the clinical advancements made thus far to improve the survival rate and heart recovery for AMI patients with cardiogenic shock, as indicated in multiple prospective studies.
Apart from meeting the primary and secondary endpoints of RECOVER IV RCT, Abiomed’s aim in conducting the trial is to achieve a global AMI cardiogenic shock Class I guideline recommendation for Impella and related best practice protocols, including Impella implantation pre-PCI.
The RECOVER III PAS has gathered real-world evidence on AMI cardiogenic shock patients treated with Impella, thus fulfilling Abiomed’s PAS requirement. The FDA’s approval and closure of RECOVER III further validate Impella as a safe and effective therapy for AMI cardiogenic shock.
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 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.
The same month, Abiomed announced that it will highlight how Impella heart pumps help heart teams achieve complete high-risk revascularization and heart recovery in the catheterization lab and operating room at the currently ongoing Transcatheter Cardiovascular Therapeutics 2022 Conference being held in Boston.
Last month, Abiomed announced favorable results from the Restore EF study, which was published online the same month in JSCAI. The result demonstrated that Impella-supported high-risk PCI leads to significant improvements in left ventricular ejection fraction, angina symptoms and heart failure symptoms at follow-up.
Price Performance
Shares of the company have lost 25.5% in the past year compared with the industry’s 31.5% fall and the S&P 500's 12.4% 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. (SWAV - Free Report) 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 4.3% compared with the industry’s 35.9% 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 33.4% against the industry’s 31.5% 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 71.5% against the industry’s 15% fall over the past year.