Medical devices including a substrate that are expandable from a compressed
state to an expanded state; a coating on the substrate, the coating having a drug
agent incorporated therein; and a sheath over the coating. The sheath is expandable
from a compressed state to an expanded state and has at least one perforation therein.
The medical devices are configured such that when the substrate is in a compressed
state, the sheath is also in a compressed state and the perforation is substantially
closed. When the substrate is in an expanded state, the sheath is also in an expanded
state and the perforation is substantially open. The invention also includes a
method of using the medical devices for the controlled, localized delivery of a
drug agent to a target location within a mammalian body.