Abiomed, Inc. announced that its Premarket Approval Application (PMA) supplement for the AB Portable driver has been approved by US FDA. This 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. AB Portable driver is a reliable cardiovascular support system that provides full Bi-Ventricular Assist Device (Bi-VAD) functionality. The device will improve 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, specifically: • The self-contained, powerful driver assists the sickest patients by 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 is based on company’s standard for quality and reliability by requiring 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 device also offers a patient-centric design including the following features: • A compact architecture that provides easy handling and transport. The driver is 25 percent smaller and 15 percent lighter compared to current portable consoles on the market, allowing easier independent patient ambulation, in-hospital transfer or land/air transportation. • Quiet operation with minimal disruption to the patient and their environment. The Portable driver is 50 percent quieter compared to current portable consoles on the market, maintaining a more unobtrusive operation and providing minimal distractions for patients and care-givers. • An advanced power system provides smart battery management. The driver 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 US approved portable console to provide this essential feature. Abiomed also received conditional IDE approval from the US Food and Drug Administration (FDA) in May 2008 to conduct a US patient discharge study with the AB Portable Driver at 20 hospitals for 30 patients. The VOYAGER I clinical study is designed to evaluate the safety and performance of the AB Portable Driver System in combination with the AB5000 Ventricle in the outpatient environment. Out of eighteen US hospital sites that have submitted for IRB review, eight hospitals have received IRB approval and are open for enrollment in the VOYAGER I trial.