Massachusetts-based heart support technologies major,
) 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.
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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
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
). We currently have a Neutral recommendation on Abiomed, which
carries a short-term Zacks #3 Rank (Hold rating).