Local Fluid Drug Delivery in Vascular Disease — Going Back to the Future

Local drug delivery for the treatment of vascular disease has been studied for many years. In coronary artery disease, drug eluting stents (DES) are routinely deployed, and drug coated balloons (DCB) have shown promise in reducing restenosis in both peripheral and coronary applications. However, a number of technical, economic and regulatory limitations and concerns of the current devices have been identified. Local or targeted fluid delivery of drugs may offer a relatively simple solution, but drug washout raises concerns of balancing efficacy with systemic drug overload. Liquid drug delivery with a device that isolates the drug at the target site would address the washout issue. The TAPAS Catheter (“Targeted Adjustable Pharmaceutical Administration System”) is a unique multipurpose local vascular drug delivery system featuring multiple drug delivery options, including an adjustable treatment length of up to 500 mm, and removal of the drug post treatment. Unlike DES and DCB, which have only a single drug and dosage for all patients, with TAPAS drug selection and dosage is upon the discretion of the physician, and may be tailored to the individual clinical requirements. In addition, (also unlike DES and DCB) TAPAS may be used multiple times in a given patient, which may translate into significant healthcare cost savings. In an initial post market surveillance analysis, TAPAS was used to deliver 9 different drugs in 7 different clinical applications; this included lytics for thrombosis and both paclitaxel and tacrolimus for prevention of peripheral vascular restenosis.