FDA Approves Abiomed's Impella CP

Massachusetts-based heart support technologies major, Abiomed Inc. ( ABMD - Analyst Report ) recently received 510(k) approval from the U.S. Food and Drug Administration (FDA) for its new Impella product dubbed Impella CP (Cardiac Power). It is known as the Impella cVAD outside the U.S. The percutaneous heart pump can successfully pump roughly 4 liters of blood in one minute.

This innovative device can pump as much as 80% of blood into the heart in one minute compared to a normal heart and is perfectly suitable to cater to heart patients requiring greater hemodynamic support. Some of its special features include ample supply of cardiac power and quick execution, indicating enhanced patient outcome.

With the much anticipated U.S. launch of the Impella CP, the company will be able to further expand its presence in the clinical heart devices market. The company plans to initially sell the product in limited quantities to top heart hospitals in the U.S. The device is expected to be commercially available in the U.S. by the fourth quarter of fiscal 2013.

The Impella cVAD received the European CE Mark in April and Health Canada approval in June. It was made commercially available at certain sites in Europe and Canada in the first quarter of fiscal 2013. The company also announced the first successful human use of the Impella cVAD outside the U.S in April.

Abiomed is enjoying strong demand for its Impella products. Impella utilization continues to grow at a healthy pace, as is evident from the increasing number of patients being treated with the device. More than 10,000 patients have been treated in the U.S. alone.

In the last reported quarter, global Impella sales jumped 56% year over year to $34.7 million. Additionally, U.S. Impella sales spiked 61% to $33 million. Abiomed opened 34 new U.S. Impella 2.5 sites in the quarter to end with a total of 665 customer sites.

Abiomed has already published three FDA studies on the Impella products viz. PROTECT I, RECOVER I and PROTECT II and there are more than 150 peer reviews available. It has also been included in the medical guidelines and has been approved for a Current Procedural Terminology (CPT) code.

While we are upbeat about the prospects of Impella, we remain cautious about the intense competition and reimbursement risks. Abiomed faces competition from organizations developing permanent heart assist products including Thoratec Corporation ( THOR - Analyst Report ) . We currently have a Neutral recommendation on Abiomed, which carries a short-term Zacks #3 Rank (Hold rating).