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Abiomed's Extended FDA Nod for Impella Boosts Women Health

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Abiomed, Inc. (ABMD - Free Report) recently announced expanded FDA Pre-Market Approval (PMA) for its flagship Impella 2.5, Impella CP, Impella 5.0 and Impella LD heart pumps. With this expanded PMA, these heart pumps can now be used to treat heart failure associated with cardiomyopathy leading to cardiogenic shock, including peripartum and postpartum cardiomyopathy (PPCM).

The latest regulatory progress is an expansion of the original FDA indication to be used for acute myocardial infarction (AMI) cardiogenic shock and post-cardiotomy cardiogenic shock (PCCS), which was received in April 2016.

The Impella Support Systems therapy aims to reduce ventricular work, to provide circulatory support for cardiac recovery and prompt assessment of the residual myocardial function.

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Data submitted to the FDA in support of the PMA indication included an analysis of 93 patients from Abiomed’s FDA-reviewed study and a literature review of 109 patients treated with Impella from 32 clinical publications.

Notably, Impella heart pumps are the only percutaneous temporary ventricular support devices that have been marked safe and effective by the FDA for cardiogenic shocks.

Women’s Initiative

This news is concurrent with the launch of an indication and a program called Women’s Initiative focused on education and awareness of heart recovery.

For women suffering from cardiogenic shock caused by cardiomyopathy, this platform provides a new treatment option, by improving outcome around heart recovery in postpartum conditions.

To note, cardiomyopathy is a disease of the heart muscle that may lead to cardiogenic shock. Such shocks are fatal since the heart is unable to pump enough blood. Additionally, myocarditis is an acute form of cardiomyopathy, affecting the younger population. It is diagnosed by cardiac dysfunction and heart failure and is responsible for roughly 10% of sudden death cases in young adults.

In women, PPCM occurs during pregnancy or after childbirth, mainly driven by cardiogenic shock. It is one of the leading causes for pregnancy-related deaths in the United States, with a mortality rate of 10%. The condition is often difficult to diagnose and may lead to poor outcome for the infant and threatens subsequent pregnancies as well.

With Impella support, patients can have minimally-invasive therapies and avoid invasive surgeries and severe drug therapy. We believe the Women’s Initiative program while creating awareness on heart recovery among women will be helpful for Abiomed in broadening the customer base for Impella heart pumps.


Per a study conducted by GlobalData, the global heart failure market is set to reach $11.8 billion in 2025 from $3.2 billion in 2015, at a compound annual growth rate of 13.7%. Increase in prevalence of chronic heart failures is a supposed growth driver.

Price Performance

Over the last year, Abiomed has gained a whopping 114.7%, surpassing the industry’s mere gain of 21.5%.



Zacks Ranks & Stocks to Consider

Abiomed carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the broader medical space are Amphastar Pharmaceuticals (AMPH - Free Report) , athenahealth, Inc. (ATHN - Free Report) and BIOVERATIV Inc. . Each of these stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Amphastar has an impressive projected long-term growth rate of 25%. The stock has returned 24.3% in the last six months.

athenahealth has an expected long-term growth rate of 23.1%. The stock has rallied 4.3% in the last three months.

BIOVERATIV has an expected long-term growth rate of 14%. The stock has gained 87.9% in the last three months.

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