Abiomed receives FDA IDE approval for new Impella RP in pivotal clinical study

theflyonthewall.com

Abiomed announced that it received Investigational Device Exemption, or IDE, approval from the FDA for the use of the new Impella RP, or Right-side Percutaneous, in a pivotal clinical study in the U.S. In the future, Abiomed plans to expand its clinical experience with the Impella RP through a pivotal biventricular "Bridge to Recovery" study, in combination with the Impella left-side devices.

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