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An intrathoracic left ventricular assist system: utilization of results from a development program
T C Rintoul1, J C Moise, K C Butler
1Nimbus, Inc., Rancho Cordova, CA 95670.
ASAIO Transactions
|July 1, 1990
Summary
Device readiness testing for an electrohydraulic left ventricular assist system (LVAS) revealed functional success but endurance limitations. Failures included environmental leakage and magnetic coupling issues, impacting long-term reliability potential.
Area of Science:
- Biomedical Engineering
- Medical Device Development
- Cardiovascular Technology
Background:
- The Nimbus/CCF left ventricular assist system (LVAS) is an intrathoracic, electrohydraulically actuated device.
- Formal device readiness testing was conducted to assess its performance and reliability.
Purpose of the Study:
- To evaluate the functional capabilities of the LVAS.
- To assess the endurance and reliability of the LVAS through testing.
- To identify failure modes during device testing.
Main Methods:
- Formal device readiness testing was performed on the LVAS.
- Eight systems underwent endurance testing.
- Failure analysis was conducted to determine root causes of system failures.
Main Results:
- All functional aspects of the LVAS were demonstrated both in vitro and in vivo.
- Four out of eight systems failed during endurance testing.
- Failures included environmental leakage (three systems) and magnetic coupling seizure due to hydrogen adsorption by samarium-cobalt magnets (one system).
Conclusions:
- The LVAS demonstrated functional success but faced challenges in long-term endurance.
- Environmental leakage and magnetic component degradation were identified as key failure modes.
- Despite program inactivity, the LVAS innovations continue to influence medical device development.