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FDA Nod for Abiomed Impella CP with SmartAssist Widens Suite
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Abiomed, Inc. recently announced the receipt of FDA Pre-Market Approval (PMA) for its Impella CPheart pump with SmartAssist, featuring an optical sensor. This will broaden the portfolio of its flagship, Impella heart pumps. The company plans a controlled roll-out of the technologically-advanced heart pump at hospital sites, with developed heart recovery protocols over the next fiscal year.
What is PMA?
Per FDA, special medical devices with a ‘Class III’ tag require a PMA nod for the availability in the markets. Notably, these Class III devices have an extremely high level of risks associated with its usage. Consequently, general regulatory approvals, alone, can’t assure the safety and effectiveness of these devices.
Abiomed’s Impella CP heart pump is a Class III medical device.
The data submitted to the FDA in support of the PMA included over 60 engineering reports and comprehensive technical specifications. Per the company, the clinical data informatics has been verified on 38 patients on the Abiomed Impella Controller at two hospitals in the United States.
Notably, the Impella 2.5 and Impella CP are the only percutaneous temporary ventricular support devices that the FDA has approved as safe and effective for High Risk PCI. Furthermore, Impella CP with SmartAssist also boasts a CE Mark approval and has already been used for treating over 60 patients at three sites.
Impella Product Line: A Major Growth Driver
Abiomed’s main product line -- Impella -- comprises Impella 2.5, Impella 5.0, Impella LD, Impella CP and Impella RP. This flagship product line continued to be growth catalyst, reflecting stellar performance in the last reported quarter as well.
Expanding the Impella portfolio, the company recently announced that Impella 2.5 and Impella CP heart-pumps have received PMA from the FDA for expanded use. With this, the products will now be used during elective and urgent high-risk percutaneous coronary intervention (PCI) procedures. Notably, it was the second PMA in a row for the devices, which was earlier granted by the FDA to treat heart failures associated with cardiomyopathy, leading to cardiogenic shock.
We encouragingly note that, in the last reported quarter, the installed customer base for Impella CP heart pumps grew by 41 new U.S. hospitals, taking the total number of Impella CP sites to 1,134. Thus, the latest FDA approval for the technologically advanced Impella CP will help the company in gaining momentum while accelerating top-line contributions from this product.
US Cardiac Disease Trends and the Cardiovascular Market
Per a research conducted by American College of Cardiology, cardiovascular diseases account for approximately 800,000 deaths in the United States. More than 90 million Americans carry a diagnosis of this disease.
According to Research and Markets, the Global Cardiovascular Implants Market is poised to grow at a CAGR of around 4.5% over the next decade.
This promising data indicates what a timely and strategic role the latest FDA approval is going to play in favor of Abiomed.
Price Performance
Over the past year, Abiomed gained a whopping 124.9%, surpassing the industry’s gain of 24.4%.
Zacks Rank & Key Picks
Abiomed carries a Zacks Rank #1 (Strong Buy).
Other top-ranked stocks in the broader medical sector are Bio-Rad Laboratories (BIO - Free Report) , athenahealth, Inc. and Edwards Lifesciences Corp. (EW - Free Report) .
athenahealth is a Zacks #1 Ranked player. It has long-term expected earnings growth rate of 21.5%.
Edwards Lifesciences has long-term expected earnings growth rate of 15.1%. The stock carries a Zacks Rank of 2 (Buy).
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
Image: Bigstock
FDA Nod for Abiomed Impella CP with SmartAssist Widens Suite
Abiomed, Inc. recently announced the receipt of FDA Pre-Market Approval (PMA) for its Impella CPheart pump with SmartAssist, featuring an optical sensor. This will broaden the portfolio of its flagship, Impella heart pumps. The company plans a controlled roll-out of the technologically-advanced heart pump at hospital sites, with developed heart recovery protocols over the next fiscal year.
What is PMA?
Per FDA, special medical devices with a ‘Class III’ tag require a PMA nod for the availability in the markets. Notably, these Class III devices have an extremely high level of risks associated with its usage. Consequently, general regulatory approvals, alone, can’t assure the safety and effectiveness of these devices.
Abiomed’s Impella CP heart pump is a Class III medical device.
The data submitted to the FDA in support of the PMA included over 60 engineering reports and comprehensive technical specifications. Per the company, the clinical data informatics has been verified on 38 patients on the Abiomed Impella Controller at two hospitals in the United States.
Notably, the Impella 2.5 and Impella CP are the only percutaneous temporary ventricular support devices that the FDA has approved as safe and effective for High Risk PCI. Furthermore, Impella CP with SmartAssist also boasts a CE Mark approval and has already been used for treating over 60 patients at three sites.
Impella Product Line: A Major Growth Driver
Abiomed’s main product line -- Impella -- comprises Impella 2.5, Impella 5.0, Impella LD, Impella CP and Impella RP. This flagship product line continued to be growth catalyst, reflecting stellar performance in the last reported quarter as well.
Expanding the Impella portfolio, the company recently announced that Impella 2.5 and Impella CP heart-pumps have received PMA from the FDA for expanded use. With this, the products will now be used during elective and urgent high-risk percutaneous coronary intervention (PCI) procedures. Notably, it was the second PMA in a row for the devices, which was earlier granted by the FDA to treat heart failures associated with cardiomyopathy, leading to cardiogenic shock.
We encouragingly note that, in the last reported quarter, the installed customer base for Impella CP heart pumps grew by 41 new U.S. hospitals, taking the total number of Impella CP sites to 1,134. Thus, the latest FDA approval for the technologically advanced Impella CP will help the company in gaining momentum while accelerating top-line contributions from this product.
US Cardiac Disease Trends and the Cardiovascular Market
Per a research conducted by American College of Cardiology, cardiovascular diseases account for approximately 800,000 deaths in the United States. More than 90 million Americans carry a diagnosis of this disease.
According to Research and Markets, the Global Cardiovascular Implants Market is poised to grow at a CAGR of around 4.5% over the next decade.
This promising data indicates what a timely and strategic role the latest FDA approval is going to play in favor of Abiomed.
Price Performance
Over the past year, Abiomed gained a whopping 124.9%, surpassing the industry’s gain of 24.4%.
Zacks Rank & Key Picks
Abiomed carries a Zacks Rank #1 (Strong Buy).
Other top-ranked stocks in the broader medical sector are Bio-Rad Laboratories (BIO - Free Report) , athenahealth, Inc. and Edwards Lifesciences Corp. (EW - Free Report) .
Bio-Rad Laboratories sports a Zacks Rank of 1. You can see the complete list of today’s Zacks #1 Rank stocks here. It has long-term expected earnings growth rate of 20%.
athenahealth is a Zacks #1 Ranked player. It has long-term expected earnings growth rate of 21.5%.
Edwards Lifesciences has long-term expected earnings growth rate of 15.1%. The stock carries a Zacks Rank of 2 (Buy).
The Hottest Tech Mega-Trend of All
Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>