Abiomed has announced that it’s now offering its more powerful Impella heart pump in the U.S., the 4L/min Impella CP (Cardiac Power). In Europe the device is known as Impella cVAD and it’s been cleared with a CE Mark in April of this year.
The Impella CP is built on the same foundation as the Impella 2.5, but provides more than a 50% increase in pumped blood volume, extending the technology for use to more acute patient cases.
From the press release:
This 510(k) clearance designates that the Impella CP has the same indications for use1 as the Impella 2.5 and includes a limitation in the Impella CP instructions for use (IFU)2.
Abiomed has three FDA studies (PROTECT I, RECOVER I, PROTECT II) that are now published on Impella, and there are also over 150 peer reviewed publications including real world usage data from the Europe and U.S. Impella registries. Additionally, Impella has been utilized to support over 10,000 U.S. patients, has been incorporated into the medical guidelines and has recently been approved for a dedicated CPT code for physician payment.