Abiomed, a provider of heart recovery products, has received FDA approval of its pre-market approval application (PMA) supplement for the AB Portable driver.
The FDA PMA approval permits the AB Portable driver to facilitate 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, according to the Danvers, Mass.-based company.
The new AB Portable driver offers a cardiovascular support system, providing Bi-Ventricular Assist Device functionality. Abiomed said that the driver is designed for clinical utility of the Abiomed AB5000 Ventricle by delivering benefits to both the hospital staff and patients by:
- The self-contained driver assists the sickest patients, offering hemodynamic support from the operating room up through the weaning process without additional computers or docking stations, required with current portable consoles.
- The AB Portable driver maintains Abiomed's standard by requiring intervals of approximately every 5,000 hours or up to seven months of operation