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Case Study

Home › Technical Disciplines › Anti-Microbial Services

Antimicrobial Medical Device Development

A medical device company, who was developing new ureteral stent designs to improve stent tolerance and reduce contact irritation symptoms in the ureter and bladder, needed to determine the encrustation potential of their designs before clinical trials could be initiated.

Altran Solutions was hired to determine the relative encrustation potential for seven different stent configurations under development. The project involved the design and construction of an encrustation test using artificial urine (AU) to determine the rate and extent of encrustation for each stent type.

A dynamic test apparatus was constructed to expose the experimental stents to simulated clinical conditions. This required the system to expose the stents to AU challenge with and without simultaneous exposure to clinically relevant microorganisms, and void and timed rapid refill of the exposure chambers at set periodic (6 hr) intervals through multiple cycles over 15 days.

The study results indicated that, except for stents that had an antimicrobial system incorporated, all stent types were observed to encrust after 6 days of exposure to inoculated and uninoculated AU. Inoculated stents exhibited the greatest amount of encrustation products of all stents, whereas, Antimicrobial stents exhibited no encrustation.

These results were critical to the advancement of the client's product to clinical trials.