Abiomed Receives FDA Clearance for Higher-Flow Impella CP Heart Pump

September 10, 2012—Abiomed, Inc. (Danvers, MA) announced that it has received 510(k) clearance from the US Food and Drug Administration for a new higher-flow version of its percutaneous, catheter-based Impella heart pump. The new Impella device provides peak blood flows of approximately 4 L/min and is delivered on the same console platform, 9-F catheter, and introducer as the Impella 2.5 device.

Abiomed advised that the device will be marketed in the United States as the Impella CP (cardiac power), beginning with a controlled launch and full commercial availability expected by the fourth quarter of the 2013 fiscal year. The device has been marketed outside the United States as the Impella cVAD, which received CE Mark approval in April 2012.

Abiomed advised that the 510(k) clearance designates that the Impella CP has the same indications for use as the Impella 2.5 and includes a limitation in the Impella CP instructions for use. The Impella CP is intended for partial circulatory support using an extracorporeal bypass control unit for periods of up to 6 hours. It is also intended to be used to provide partial circulatory support (for periods of up to 6 hours) during procedures not requiring cardiopulmonary bypass. The instructions for use advise that the safety and effectiveness of the Impella CP have not been established for use in providing partial or full support of the blood circulation for periods of > 6 hours, or for providing prophylactic hemodynamic support, for example, in patients with stable hemodynamics during percutaneous interventional procedures in high-risk coronary artery lesions and/or anatomy.

The company noted that the Impella CP is supported by three published studies: PROTECT I, RECOVER I, and PROTECT II, and it has been incorporated into the medical guidelines. Additionally, evaluation of the device in the limited market release in Europe validated the performance and ease of use of the new Impella pump, introducer, and Automated Impella Controller operating software.

“The clinical community has been anxiously anticipating the arrival of this new Impella pump,” commented John Lasala, MD, who is Medical Director of Washington University School of Medicine in St. Louis. “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.”