Abiomed, Inc. (NASDAQ:ABMD) recently announced that its flagship Impella 2.5 and Impella CP heart-pumps have received Pre-Market Approval (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, this is the second PMA in a row for the devices, which was earlier granted by the FDA to treat heart failure associated with cardiomyopathy, leading to cardiogenic shock.
Such consents affirm the effectiveness of Impella in patients diagnosed with severe coronary artery diseases, complex anatomy and additional ailments.
The latest PMA for Impella to treat High Risk PCI was based on two studies by the FDA; PROTECT I and PROTECT II. The studies included treatment of patients with most severe conditions in the catheterization lab, with the majority being denied open-heart surgery.
The data submitted to the FDA in support of the PMA included an analysis of 229 consecutive patients with mild to moderately-reduced ejection fraction (EF), who were also denied open-heart surgery, owing to surgical risk factors.
The acclaim further validates this ‘first of its kind’ indication for High Risk PCI and the benefit of percutaneous hemodynamic support in treating severely complex patients with mild, moderate and severely depressed EF.
Why Impella?
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. Per the FDA, the devices provide temporary ventricular support (less than six hours). It was further stated that the use of the Impella platform may reduce hemodynamic instability, beside reducing peri- and post-procedural adverse events.
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.
Price Performance
In the last six months, Abiomed has outperformed the industry in terms of price. The stock has returned 69.8%, compared with the industry’s gain of 14.6%.
Zacks Ranks & Key Picks
Abiomed carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are Centene Corporation (NYSE:CNC) , Haemonetics Corporation (NYSE:HAE) and HCA Healthcare (NYSE:HCA) . Each of these stocks sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Centene has projected a long-term growth rate of 14.4%. The stock has returned 19.3% in the last six months.
Haemonetics has a positive long-term growth rate of 10.8%. The stock has returned 67.9% in the last six months.
HCA Healthcare has an expected long-term growth rate of 11.5%. The stock has returned 34.2% in the last three months.
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ABIOMED, Inc. (ABMD): Free Stock Analysis Report
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HCA Holdings, Inc. (HCA): Free Stock Analysis Report
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