Abiomed, medical device company, has won FDA 510(k) clearance for new, high flow percutaneous, catheter-based Impella device with peak flows of approximately four liters of blood per minute.
The new percutaneous heart pump, which is delivered on the same console platform, 9 French catheter, will be marketed in US as Impella Cardiac Power (CP) and is commercially known as Impella cVAD outside the US.
Washington University School of Medicine medical director John Lasala said the Impella CP promises a substantial amount of cardiac power, can be inserted quickly, and is ideal for patients that require more hemodynamic support.
"It is exciting for physicians to be able to provide this type of percutaneous support that represents approximately 80% of what a healthy heart can pump each minute," Lasala added.
The Impella CP has similar indications for use as Impella 2.5 and includes a limitation in the Impella CP instructions for use (IFU).
Abiomed considers launching Impella CP with top heart hospitals in the US, and full US commercial availability is expected by the fourth quarter of fiscal 2013.
Abiomed chairman, president and chief executive officer Michael Minogue said, "The addition of the Impella CP to the growing Abiomed product portfolio further emphasizes the company’s commitment to innovation and our dedication to patients."