Recent Developments in Drug-Coated Balloons – Part 1

Drug-coated balloons (DCB), also referred to as drug-eluting balloons (DEB), were created as a way to reduce very high restenosis rates in peripheral vessels. They also have been investigated in clinical trials to prevent coronary artery in-stent restenosis.

The surface of these balloons carry antiproliferative drugs such as paclitaxel or sirolimus that is delivered to the vessel wall when inflated. The drug helps prevent neointimal hyperplasia (scar tissue growth) caused by trauma when the vessel segment is treated for atherosclerotic lesions with balloon angioplasty. DCBs are now approved in the U.S. Food and Drug Administration (FDA) clearance for the treatment of peripheral artery disease (PAD) in the legs and hyperplasia in arteriovenous (AV) access fistulae in dialysis patients. DCBs also are used outside the U.S. to treat in-stent restenosis due to scar tissue proliferation inside stents. Several DCBs are designated as FDA breakthrough devices for this application.

Several DEBs have gained FDA breakthrough device designation as medical devices that provide the potential for a more effective treatment option for life-threatening or irreversibly debilitating diseases. Manufacturers are then able to offer patients and healthcare providers quicker access to new medical devices by expediting the development, assessment and review process.

The key differentiating aspects of DCBs are what drug is used and how it is attached to the balloon surface. Some balloons use an excipient to hold the drug in place so it does not immediately wash off in the blood, others use special surface coatings or preparations to adhere the drug directly to the balloon surface. Excipient drug carriers include the use of iodine contrast, polyethylene glycol and bioresorbable materials.

The type of crystal formation (i.e. amorphous, anhydrous, crystalline nanospheres, microcrystals) used for drugs also plays a role in the pharmokinetics of anti-proliferative in terms of the time it takes to transfer into the vessel endothelium and the duration of elution after delivery.