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Abiomed's (ABMD) Impella 5.5 With SmartAssist Gets FDA Nod

Zacks Equity Research

Abiomed, Inc.’s ABMD newest heart pump, the Impella 5.5 with SmartAssist, recently received FDA pre-market approval based on its safety and efficacy in the therapy of cardiogenic shock. Notably, the Impella 5.5 with SmartAssist will be introduced in the United States through a controlled rollout at hospitals.

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

The Impella 5.5 heart pump with SmartAssist is minimally invasive and specifically designed for heart surgeons. The SmartAssist enables the pump to provide algorithms to optimize recovery and survival. Impella heart pumps are designed to reduce ventricular work and provide the circulatory support required for heart recovery.

Impella — A Major Growth Driver

Being ABIOMED’s flagship product line, Impella has been a consistent growth driver and is expected to contribute to results in the future as well. ABIOMED has been steadily investing to expand the platforms of Impella CP, Impella Connect, Impella 5.5 and Impella RP.

In fact, in the last reported quarter, Impella RP saw 18% year-over-year growth.

That’s not all. Impella has seen a slew of developments in recent times.

For instance, in May, the company announced that its Impella CP with SmartAssist will be commercially available in the United States. Additionally, the FDA approved the expansion of Abiomed’s flagship Impella 5.0 and Impella LD for treating cardiogenic shock.

Internationally as well, Impella enjoys a strong foothold.

Notably, in Europe, the Impella 2.5, Impella CP and Impella CP with SmartAssist are CE marked for treatment of high-risk percutaneous coronary intervention and cardiogenic shock patients. The Impella 5.5 heart pump is CE-marked to treat heart attack or cardiomyopathy patients in cardiogenic shock.

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, an expanding economy and rising awareness of healthcare fuel growth.

Hence, the latest development is likely to prove to be a beneficial one for Abiomed.

However, the company faces stiff competition from the likes of Medtronic MDT, Boston Scientific BSX and Johnson & Johnson JNJ in the cardiovascular space.

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