Abiomed has recently signed a long-term operating lease for a manufacturing facility in Athlone, Ireland, and the company expects to begin facility preparations immediately.
The company currently anticipates that the first Impella 2.5 cardiac assist device production line will be operational in approximately eighteen months. The Impella 2.5 capacity expansion plans in Ireland are intended to meet demand for the device and augment capacity from the company’s Aachen, Germany facility, Abiomed said.
In June, Abiomed received FDA 510(k) clearance for its Impella 2.5 that allows Abiomed to begin selling the device in the United States.
The Danvers, Mass.-based company reported that the Ireland facility has a total of 33,000 square feet of space, including approximately 10,000 square feet of finished space. The company indicated that the longer-term plans for the Ireland facility will be to designate Ireland as its global center of excellence for high-volume disposable products manufacturing.