The Taxus drug-eluting stent: a new paradigm in controlled drug delivery.

The advent of drug-eluting stents (DES) has provided the medical community with a technology that is transforming the treatment of coronary artery disease. As the newest treatment modality available to the interventional cardiologist, drug-eluting stents have not only significantly reduced the risk of restenosis, but they are also allowing the interventionalists to treat more complex lesions in patients that would otherwise require more invasive bypass surgery. Development of these drug-device combination products has presented considerable challenges to the device industry because it involves a multi-disciplinary approach that combines conventional device design and manufacturing with the principles of controlled local drug delivery. This review article provides an in-depth discussion of the key elements of drug-eluting stents, focusing on the TAXUS paclitaxel-eluting stent as an example of this new class of product. Specific sections will review the drug and polymer matrix components, formulation development and evaluation, pre-clinical studies and clinical trial results.