Massachusetts-based heart support technologies major,
Abiomed Inc.
(
ABMD
) has received the Health Canada nod to launch its Impella cVAD
heart pump. Per the approval, the Impella cVAD can be used as a
support system in cardiac surgery and cardiology for up to 5 days.
With the Canadian launch of the product, the company will be able
to further expand its presence in the international medical devices
market.
The Impella cVAD is an intracardiac catheter-based pump, which
provides circulatory support to the left ventricle of the heart.
The device can pump up to 4 liters of blood in one minute. This
renders flexibility to doctors to increase the flow for patients in
need of more hemodynamic support.
Abiomed is enjoying strong demand for its Impella products.
Impella utilization continues to grow at a healthy pace as evident
from the increasing number of patients being treated with the
device. The Impella cVAD, the latest addition to the Impella
family, is expected to be accretive to the company's revenues in
the near term.
Abiomed's revenues soared 31% year over year to $37.3 million (a
quarterly record) in the fourth quarter of 2012. Growth was led by
solid sales of Impella heart pumps. Globally, Impella sales rose
43% year over year to $32.3 million in the reported quarter.
Impella sales in the U.S. spiked 44% to $29.9 million. Also,
Abiomed announced the first successful human use of its
percutaneous Impella cVAD heart pump outside the U.S. in the fourth
quarter.
Abiomed announced, in April, CE Mark approval for its Impella
cVAD in the European Union. It is expected to become commercially
available in Europe in early fiscal 2013. However, the Impella cVAD
is not commercially available in the U.S. The company expects to
receive 510(k) approval for the product by the second half of
fiscal 2013.
While we are upbeat about the prospects of Impella, we remain
cautious about the intensely competitive environment and
reimbursement risks. Abiomed faces competition from organizations
developing permanent heart assist products such as
Thoratec
Corporation
(
THOR
).
We currently have a long-term Outperform rating on Abiomed. The
stock holds a short-term Zacks #3 Rank (Hold).
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