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Abstracts: ASAIO Cardiac Abstracts


Rossi, Stephen A1; Reichenbach, Steven H1; Lind, Jeff R1; Narum, Jeff1

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The design intent of the IVAD was to provide a small, reliable, implantable, pulsatile pump for right, left and bi-ventricular support. Based on a clinical trial conducted in Europe and the US, the CE mark was obtained (July 2003), and FDA approval was received (August 2004). Device reliability and performance was evaluated using in vitro testing, explanted device evaluation, investigation of adverse events, and review of the commercial device registry. In the clinical trial, 30 patients (19 LVAD and 11 BVAD, 22 males and 8 females, BSA ranging from 1.31 to 2.35) were supported for 9 to 298 days (6.7 pt-years total), of whom 11 were discharged from the hospital for 3 to 213 days (2.3 pt-years total). There were no incidents of lost support, pump failure, or devices requiring replacement. In addition, 36 commercial implants have been reported (17 LVAD, 16 BVAD, and 3 RVAD, 29 males and 7 females). The longest IVAD patient has been supported for over 1.5 years. In vitro testing of 8 pumps has continued over 2.5 years without loss of pump function. No significant pump anomalies were found in 33 explanted pumps. Based on clinical results during the trial, design enhancements to improve sensor performance and cannula connector ease of use have been developed and implemented. Additional cannulae and modified electrical connectors are in the final stages of development and implementation. Based on clinical device performance, the IVAD design has met intended objectives, providing a reliable, versatile, implanted VAD. Clinical experience has continued to drive device enhancements.

Copyright © 2005 by the American Society for Artificial Internal Organs