Abiomed wins US FDA approval for new Impella product
Abiomed Inc said it has secured approval from the U.S. Food and Drug Administration for its new Impella product dubbed Impella CP (Cardiac Power).
The product is known by the name of Impella cVADoutside U.S. This device can pump as much as 80% of blood into the heart in a minute compared to a normal heart and is suitable for heart patients that require greater hemodynamic support.
With the much anticipated launch of the device Impella CP in the U.S., Maschusetts-based heart support Technologies Company will be able to further expand its presence in the clinical devices market.
Abiomed initially plans to sell the product to well-known heart hospitals in the U.S. Impella CP is likely to be commercially available in the U.S. by the fourth quarter of fiscal 2013.
The heart support technologies company also announced the first successful human use of Impella cVADoutside the U.S. in April.
Abiomed is enjoying strong demand for its Impella products. Global sales of Impella rose 56% year over year to $34.7 million in the last reported quarter. The sales of Impella in U.S. spiked 61% to $33 million. It also opened 34 new U.S. Impella 2.5 sites in the quarter to end with a total of 665 customer sites.
Abiomed is a global leader in healthcare technology and innovation.