Biomaterial considerations for drug-eluting stents.

The ultimate test for implant biomaterials is determined by the long-term, post-market clinical product performance. This is a key consideration in the initial design and development for drug-eluting stents. To insure this ultimate clinical success, a rigorous series of bench-top, preclinical and clinical evaluations must be performed.

A dissolution-diffusion model for the TAXUS drug-eluting stent with surface burst estimated from continuum percolation.

A two-layer dissolution-diffusion model is derived which incorporates a surface burst component that is estimated from continuum percolation models of overlapping Poisson distributed spheres. The model is shown to adequately describe the release properties of paclitaxel from a hydrophobic polymer matrix, including the surface burst and sustained release dependence on drug loading.