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FDA Okays Abiomed's First-in-Human Trial Of Heart Pump, Impella ECP

Abiomed (ABMD) said that the United States Food and Drug Administration has approved the company's investigational device exemption application to start an early feasibility study with a first-in-human trial of the 9 French (Fr) Impella ECP™ heart pump.

Impella ECP, which stands for expandable cardiac power, will be studied in high-risk percutaneous coronary intervention (PCI) patients.

The company noted that Impella ECP is the world's smallest heart pump. It achieves peak flows greater than 3.5 L/min and is delivered though a slender-profile sheath.

The company said that Impella ECP is available for investigational use only and is not approved for use outside of clinical studies.

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