FDA Approves Abiomed’s New AB Portable Driver for Patient Transport, Mobility, Ambulation
April 1, 2009 - Abiomed Inc. said this week the FDA cleared its 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.
The company said its new AB Portable driver offers a reliable cardiovascular support system, providing full bi-ventricular assist device (Bi-VAD) functionality. The new driver is designed to enhance the clinical utility of the Abiomed AB5000 Ventricle by delivering direct benefits to both the hospital staff and patients by increasing mobility and versatility without compromising performance.
The device is said to be a powerful, self-contained driver to assist the sickest patients, offering hemodynamic support directly from the operating room up through the weaning process without additional computers or docking stations, which are required with current portable consoles.
The AB Portable driver requires low-maintenance intervals of approximately every 5,000 hours or up to seven months of operation, which is estimated to be three times longer than existing portable consoles, the company said.
“Patients on full BiVAD support for heart recovery often require mobility and transport in order to provide a comprehensive assessment for a next stage of therapy,” said Mark Anderson, M.D., department of cardiothoracic surgery, Robert Wood Johnson University Hospital. “The AB Portable driver is lightweight and compact and the quietest portable Bi-VAD console on the market, yet still provides that full level of Bi-VAD support from the minute you leave the surgery suite.”
The device has compact architecture that enables easy handling and transport. The driver is 25 percent smaller and 15 percent lighter than current portable consoles on the market, allowing easier independent patient ambulation, in-hospital transfer or land/air transportation, the company said.
Abiomed said the device offers quiet operation with minimal disruption to the patient and their environment. The portable driver is 50 percent quieter than current portable consoles on the market, maintaining a more unobtrusive operation and providing minimal distractions for patients and caregivers.
An advanced power system that offers smart battery management can operate up to 10 hours without recharging and includes an integrated battery-gauge display that offers the user real-time battery status displayed in hours and minutes. The AB Portable driver is the only U.S. approved portable console to provide this essential feature.
Separate from the PMA supplement, Abiomed received conditional IDE approval from the FDA in May 2008 to conduct a U.S. patient discharge study with the AB Portable Driver at 20 hospitals for 30 patients. The VOYAGER I clinical study aims to evaluate the safety and performance of the AB Portable Driver System in combination with the AB5000 Ventricle in the outpatient environment. Of the eighteen U.S. hospital sites that have submitted for IRB review, eight hospitals have received IRB approval and are open for enrollment in the VOYAGER I trial.
For more information: www.abiomed.com