Impella® Platform
Percutaneous, Catheter Based
Impella 2.5
In June 2008, the Impella 2.5 received FDA 510(k) clearance for partial circulatory support for periods up to 6 hours.
Impella 5.0
In April 2009, the Impella 5.0 received FDA 510(k) clearance circulatory support for periods up to 6 hours.
Impella LD
In April 2009, the Impella LD received FDA 510(k) clearance circulatory support for periods up to 6 hours.
Automated Impella Controller
In July 2010, the Impella® Controller received FDA 510(k) clearance for intended use by trained healthcare professionals in healthcare facilities and medical transport (ie, ambulance, helicopter, or fixed-wing aircraft) environments.
AB™ Platform
Ambulatory, Biventricular
AB5000 Ventricle
In April 2004, the AB5000 ventricle received pre-market approval (PMA) to provide temporary support for one or both sides of the heart, giving the patient's heart the opportunity to rest and potentially recover
AB Portable Driver
In March 2009, the AB Portable received pre-market approval (PMA) for intra-facility patient transport, patient mobility for participation in physical and rehabilitation therapies, independent ambulation by the patient, and inter-hospital transport via aircraft or ambulance.