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Excerpt
Methods: A major issue with long-term use of VADs outside of the hospital setting, is patient acceptability and quality of life. To address this issue, the HeartSaver VAD development program focused on 2 areas: 1) Implantability, and 2) Recipient Quality of Life Post-Implant. To improve implantability, the device is designed to be implanted in the thoracic cavity (via median sternotomy). The device will be anchored to the rib cage to eliminate device dislodgement. To improve recipient lifestyle, the device will be remotely monitored and controlled, freeing the patient from the need to frequently visit the hospital and allowing greater peace of mind for the recipient. The device utilizes remote power transfer and an internally implanted battery allows the recipient to indulge in a wide range of normal lifestyle activities (bathing, swimming, showering, changing clothes, etc.), unencumbered by any external components, further enhancing quality of life and freedom of movement.
Results: The first prototype of the device has been operating on the bench for over 7 years failure free. Three series of in vivo studies (N=43) in bovine, for up to 30 days of support, have been conducted, demonstrating: 1) device implantability, 2) performance & ability to sustain circulation, and 3) remote monitoring and control capabilities. Studies to date, have demonstrated acceptable implantability and performance of the developed device. Based on these studies, a refined version of the device (pre-clinical version) was developed and manufactured. In vitro and in vivo studies of this pre-clinical version of the device are currently underway in preparation for clinical trials.
