WASHINGTON (dpa-AFX) - 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 ECPT 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.
Copyright RTT News/dpa-AFX
© 2020 AFX News
