Abiomed's Impella devices keep pumping with another 510(k) clearance

Abiomed ($ABMD) gained FDA clearance for another iteration of its Impella heart pump, an important win for a product line that's become vital to Abiomed's bottom line.

The latest Impella, dubbed Impella CP in the U.S., is a catheter-based device designed to be implanted under the skin to give partial circulatory support for up to 6 hours as needed during medical procedures not involving cardiopulmonary bypass.

Abiomed gained a CE mark in April for the device, and it is marketed outside the U.S. as the Impella cVAD.

Consider the following: Impella products are driving Abiomed's future in a big way. The Danvers, MA, device company booked $126.4 million in revenue for fiscal 2012, ending the year in the black for the first time in 15 years. Of that number, Impella products generated nearly $107 million in revenue, the vast majority of which came from the U.S. Impella has now helped treat more than 10,000 U.S. patients and has gained crucial, designated codes for physician reimbursement payment, the company notes.

Abiomed said its fiscal 2013 first quarter revenue reached $38.8 million, with $3.1 million in net income, marking record levels for the company. Once again, Impella's expansion drove the numbers.

- read the release

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