Coated medical device

A method of delivering paclitaxel to an inner wall of a blood vessel from a balloon catheter having an expandable balloon with a coating on an outer surface of the balloon, the method comprising:

• providing a balloon catheter including a balloon with a dried coating consisting of paclitaxel or a mixture of paclitaxel with another bioactive agent, the dried coating being free of any additional coating atop the dried coating, where the paclitaxel or mixture of paclitaxel with another bioactive agent is not incorporated within a containment layer, and where the balloon has folds and portions of the dried coating are positioned in the folds;
• advancing the balloon within the blood vessel to a treatment site;
• inflating the balloon to directly contact the paclitaxel or mixture of paclitaxel with another bioactive agent with an inner wall of the blood vessel;
• and
• delivering the paclitaxel or mixture of paclitaxel with another bioactive agent to the inner wall of the blood vessel while maintaining the paclitaxel or mixture of paclitaxel with another bioactive agent in direct contact with the inner wall of the blood vessel while the balloon is inflated.

A method of delivering paclitaxel to an inner wall of a blood vessel of a patient from an implantable medical device having an expandable balloon with the paclitaxel on an outer surface of the balloon, the method comprising the steps of:

• providing an angioplasty balloon having a dried layer of coating material containing paclitaxel on the outer surface of the balloon, wherein the dried layer of coating material is the only layer on the balloon, wherein the balloon has folds configured to unfurl upon inflation of the balloon, and wherein portions of the dried layer are positioned in the folds;
• advancing the balloon within the blood vessel to a treatment site within the blood vessel;
• inflating the balloon at the treatment site so as to cause the folds to unfurl so that portions of the balloon come into rotational wiping contact with the inner wall of the blood vessel during which amounts of the coating material containing paclitaxel are transferred to the inner wall of the blood vessel;
• maintaining the inflated balloon in contact with the inner wall of the blood vessel;
• deflating the balloon after said maintaining;
• and
• removing the deflated balloon from the blood vessel.