ABIOMED's Impella 5.0 And LD Receive Expanded FDA Approvals

ABIOMED, Inc. (NASDAQ:ABMD) recently announced FDA approval for the expansion of its flagship Impella 5.0and Impella LD for treating cardiogenic shock. Notably, this approval means that the duration of support for each Impella pump can be expanded from six to 14 days.

This fortifies the company’s foothold in the cardiovascular devices market.

Notably, ABIOMED’s much coveted Impella heart pumps have the PMA (pre-market approval) from the FDA to treat cardiogenic shocks and shocks associated with peripartum cardiomyopathy or myocarditis.

More on Impella

The Impella 5.0 is an intravascular microaxial blood pump, while the Impella LD being a minimally-invasive catheter-based percutaneous device.

Other versions of this device are Impella 2.5 and Impella CP which have also been approved by the FDA to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions.
It is encouraging to note that in the recently reported fourth quarter of fiscal 2019, the Impella CP received PMDA approval in Japan.

Moreover, the STEMI DTU Pivotal study was approved based on the company’s first submission and requested protocol, which will be used for obtaining FDA approval.

Market Prospects

The Business Research Company suggests that the cardiovascular devices market is expected to reach a value of nearly $80.68 billion by 2022, at a CAGR of 5.7%. New health reforms, a growing economy and rising awareness of healthcare fuel growth.

Price Performance

We believe that positive developments such as these will boost the Zacks Rank #4 (Sell) stock, which has lost 32.9% compared with the industry’s 1% decline in a year’s time. The current level also compares unfavorably with the S&P 500 index’s 4.8% rally.

Key Picks

Some better-ranked stocks in the broader medical space are DENTSPLY SIRONA (NASDAQ:XRAY) , Masimo Corporation (NASDAQ:MASI) ad CONMED Corporation (NASDAQ:CNMD) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

DENTSPLY’s long-term earnings growth rate is expected at 11.5%.

Masimo’s long-term earnings growth rate is projected at 16.1%.

CONMED’s long-term earnings growth rate is estimated at 13.3%.

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