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Abiomed's (ABMD) Latest Impella Offering Approved by the FDA
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Abiomed, Inc. recently received the FDA’s 510(k) clearance for its Impella Low Profile Sheath. The company plans to commence its phased roll-out in the fiscal third quarter of 2023.
The latest regulatory clearance for Impella Low Profile Sheath is a significant stepping stone for Abiomed’s coronary business across the world.
Significance of the Approval
Abiomed’s latest Impella Low Profile Sheath has a slightly lesser outer diameter (unlike the existing 14 French sheath) with the same inner diameter used for placement of Impella CP. The smaller size of the Low Profile Sheath and other technological advancements will likely facilitate easier Impella insertion and removal and reduce procedural steps, thereby improving patient outcomes.
The Low Profile Sheath is currently the first sheath which has been specifically designed to be compatible with the Impella single-access technique. This eliminates the need for any additional access site, besides having a few other advantages like minimizing vascular complications and bleeding, among others.
Per management, the Low Profile Sheath is expected to further improve patient outcomes by making it easier for physicians to insert, manage and remove Impella heart pumps.
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 that the FDA has accepted and closed the post-approval study reports related to the pre-market approvals for Impella heart pumps.
Last month, Abiomed 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 same month, Abiomed 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 patients.
Price Performance
Shares of the company have lost 29.3% in the past year compared with the industry’s 35.4% decline and the S&P 500's 20.2% fall.
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 gained 17.9% against the industry’s 39.8% decline in the past year.
ShockWave Medical, sporting a Zacks Rank #1 at present, has an estimated growth rate of 33.5% for 2023. SWAV’s earnings surpassed estimates in all the trailing four quarters, the average beat being 180.1%.
ShockWave Medical has gained 24.2% against the industry’s 35.4% decline 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 74.7% against the industry’s 16.6% decline over the past year.
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Abiomed's (ABMD) Latest Impella Offering Approved by the FDA
Abiomed, Inc. recently received the FDA’s 510(k) clearance for its Impella Low Profile Sheath. The company plans to commence its phased roll-out in the fiscal third quarter of 2023.
The latest regulatory clearance for Impella Low Profile Sheath is a significant stepping stone for Abiomed’s coronary business across the world.
Significance of the Approval
Abiomed’s latest Impella Low Profile Sheath has a slightly lesser outer diameter (unlike the existing 14 French sheath) with the same inner diameter used for placement of Impella CP. The smaller size of the Low Profile Sheath and other technological advancements will likely facilitate easier Impella insertion and removal and reduce procedural steps, thereby improving patient outcomes.
The Low Profile Sheath is currently the first sheath which has been specifically designed to be compatible with the Impella single-access technique. This eliminates the need for any additional access site, besides having a few other advantages like minimizing vascular complications and bleeding, among others.
Per management, the Low Profile Sheath is expected to further improve patient outcomes by making it easier for physicians to insert, manage and remove Impella heart pumps.
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 that the FDA has accepted and closed the post-approval study reports related to the pre-market approvals for Impella heart pumps.
Last month, Abiomed 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 same month, Abiomed 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 patients.
Price Performance
Shares of the company have lost 29.3% in the past year compared with the industry’s 35.4% decline and the S&P 500's 20.2% fall.
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 gained 17.9% against the industry’s 39.8% decline in the past year.
ShockWave Medical, sporting a Zacks Rank #1 at present, has an estimated growth rate of 33.5% for 2023. SWAV’s earnings surpassed estimates in all the trailing four quarters, the average beat being 180.1%.
ShockWave Medical has gained 24.2% against the industry’s 35.4% decline 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 74.7% against the industry’s 16.6% decline over the past year.