Mechanical properties and imaging characteristics of remanufactured intravascular ultrasound catheters.

Abstract

Intravascular ultrasound (IVUS) as a routine device in interventional cardiology is handicapped by its high price. 19 factory-made, 'remanufactured' IVUS catheters which consist of sterilized, used phased-array IVUS transducers inserted into a new catheter shaft were compared with 23 new IVUS catheters. 3 mechanical and 4 imaging characteristics were assessed on a 5 point scale (1 = unacceptable, 5 = excellent). Mechanical as well as imaging properties of 'remanufactured' IVUS catheter were comparable to new catheters with excellent ratings for each of the evaluated characteristics in 38 to 94% of 'remanufactured' catheters and 50 to 96% of new catheters. The initial failure rate for 'remanufactured' IVUS catheters was 31.6% vs. 4.3% for new catheters (P < 0.05). Overall failure rate was 47.3% for "remanufactured" catheters vs. 8.7% for new catheters (P < 0.05). The failure was due to an electronic connecting problem occurring during mechanical stress to the IVUS catheter. In conclusion, 'remanufactured' IVUS catheters offer mechanical and imaging characteristics which are comparable to new catheters. Improvements in the 'remanufacturing' process to resolve the high rate of electronic connecting problems may make this a promising approach to substantially lower the price of IVUS catheters.