The expansion, driven by a pair of recent regulatory wins, is slated to add 85,000 square feet to Abiomed’s operation on Boston’s North Shore, which employs about 600 workers.
In March, the FDA approved Abiomed’s flagship Impella 2.5 heart pump, nearly 3 years after the safety watchdog’s Circulatory Devices advisory panel recommended that it be subject to the FDA’s most stringent PMA protocol. The pump had been allowed on the U.S. market via the FDA’s 510(k) clearance program. Last October Abiomed said it had reached a deal with the federal safety watchdog on the indication for Impella 2.5.
Last January Abiomed notch a win for its Impella RP device, winning a humanitarian device exemption for the 1st FDA-approved percutaneous, single-access pump for supporting the heart’s right ventricle.
“Our recent FDA approvals for the Impella devices give us the license to become the standard of care. In preparation for this, we have doubled our current footprint and are currently making Impella pumps in our Danvers and Aachen, Germany offices. With this building expansion, we are planning for success by expanding our manufacturing capacity and developing a world-class training center for healthcare professionals from all over the world. In the next 2 years, we expect to create more than 100 jobs in our headquarters facility in Danvers,” chairman, president & CEO Michael Minogue said today.
Abiomed has been riding a wave of other good news this year, in addition to the regulatory approvals. Last month ABMD shares hit yet another all-time high on the strength of its fiscal 4th-quarter results. In February an appeals court upheld the dismissal of a shareholders lawsuit, 1 of several brought after a pair of FDA warning letters in 2010 and 2011 sent its share price plummeting.
Last summer the company prevailed in 1 of those suits when the U.S. Court of Appeals for the 1st Circuit upheld a district court’s dismissal of the case.
ABMD shares were trading at $65.56 apiece in mid-day activity, down slightly.