International Applied Reliability Symposium (ARS): An international reliability and maintainability conference event

Session 3
11:30 a.m. to 12:30 p.m. Wednesday September 13, 2006

In Vitro Reliability Testing of the VentrAssist™ Left Ventricular Assist System

Ventracor reliability testing of the VentrAssist™ Left Ventricular Assist System (LVAS) has an initial objective of demonstrating sufficient reliability for clinical use as a long-term circulatory support system in destination therapy. The testing consists of a real time Life Cycle Validation Test (LCVT) using a simulated circulatory loop representative of implanted conditions.

The minimum reliability requirement was derived from the STS-ASAIO Long Term Mechanical Circulatory Support System Reliability Recommendation of 80% reliability at 60% confidence level for a 1 year mission life.

This presentation will consider a Weibull analysis approach where few or no failures have occurred to provide a conservative estimate of the minimum reliability demonstrated by the in vitro testing.

 

 
Stephen Gangell
Ventracor, Australia