An ultralow dose paclitaxel coated drug balloon with an outer protective sheath for peripheral arterial disease treatment

Use of a drug-eluting coated balloon (DCB) represents a promising therapeutic method for peripheral arterial disease (PAD) due to its advantages such as no implant permanently retained in the patient and no inflammatory reaction and endothelialization barrier caused by a permanent stent. However, there is still a huge challenge of controlling the release of drugs from the DCB into vessel tissue. The uncontrolled release of drugs and high drug loading amounts could potentially lead to distal embolization and mortality events. In our study, an ultralow dose paclitaxel (PTX) coated DCB appended with an outer protective sheath was designed to treat peripheral vessel stenosis. An in vitro study demonstrated that the sheath could significantly reduce the drug loss during the delivery process and the meglumine matrix could effectively promote the transfer of PTX into vessel tissue. The pharmacokinetics study in the swine model also demonstrated that the PTX amount remaining in the vessel after being treated by our DCB was comparable to similar products on market although only less than a third of the PTX was used. The safety study indicated that the DCB treatment did not have any adverse impact on the physiological function of the vessel. Therefore, our ultralow dose PTX coated DCB could provide an effective and safe treatment for PAD.