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 CP
In September 2012, the Impella CP received FDA 510(k) clearance 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
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.
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
