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Abiomed's Impella Heart Pumps Get Additional FDA Approval

Abiomed Inc. ABMD recently announced that the FDA has approved its Impella left side heart pumps for treating patients who suffer cardiac shock after heart attack or heart surgery. The share price inched up a mere 0.6% post the approval which was highly anticipated.

Last month, the company had indicated in a regulatory filing that an advisory committee review prior to pre-market (PMA) approval may not be needed for the Impella devices. Impella product portfolio comprises Impella 2.5, Impella CP, Impella 5.0, Impella LD and Impella RP.

In Mar 2015, Impella 2.5 the world's smallest heart pump received FDA Pre-Market Approval (PMA) for use in high risk PCI procedures. Impella 2.5 was the first hemodynamic support device to be permitted for such an indication. Earlier, in January, the Impella RP device received Humanitarian Device Exemption (HDE) approval.

In the current indication, Impella devices will help the heart pump blood, allowing the left ventricle to rest while a surgeon performs the surgery. Per FDA, as quoted by Abiomed “The intent of the Impella system therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.”

The approval significantly expands Abiomed’s total addressable market. Currently, the company treats around 5% of its patients who suffer from acute myocardial infarction (AMI). This patient population suffers one of the highest mortality risks in heart hospitals.

The approvals have ramped up adoption of Impella products, which accounted for 94.4% of total revenues in the third quarter of fiscal 2016. Impella patient usage soared 45% in the U.S., driven by growing adoption of protected PCI (up 59%) and emergent support (up 45%). U.S. reorder rate grew 49% year over year to $69.3 million.

Abiomed revealed that an additional 20 hospitals purchased Impella 2.5 heart pumps during the quarter, taking the installed customer base to 1,020 sites. As part of Abiomed's continued Impella CP launch, 49 new hospitals purchased the device during the quarter, reaching the U.S. site count to 788.

Abiomed noted that an additional 17 sites made initial purchases of Impella RP, reaching the total number of Impella RP U.S. sites to 71 at the end of the quarter. This surpassed the company’s initial fiscal year target of 60 sites.

We believe that the extended indication of the Impella heart pumps will drive Abiomed’s top line in fiscal 2017 and beyond.

Zacks Rank & Key Picks

Abiomed has a Zacks Rank #3 (Hold). Better-ranked stocks in the same space are Inogen INGN, Luminex LMNX and Globus Medical GMED. All the three stocks carry a Zacks Rank #2 (Buy).

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LUMINEX CORP (LMNX): Free Stock Analysis Report
ABIOMED INC (ABMD): Free Stock Analysis Report
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GLOBUS MEDICAL (GMED): Free Stock Analysis Report
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