New Drug Delivery Device Could Transform Treatment for Kidney Disease Patients

The Drug-Eluting Cuff (DEC), developed by Cylerus, Inc. (Melbourne, FL), is an innovative new medical device that can dramatically reduce treatment complications for patients with end-stage renal disease who require life-sustaining hemodialysis. The DEC’s novel design offers dramatic improvements over current dialysis treatment technology, by combining safe and continuous local drug delivery to prosthetic vascular grafts. This device is designed to prevent the high clinical failure rate of prosthetic grafts, which is almost 50% at three months post-graft implantation.

People with end-stage renal disease (ESRD) lose the ability to eliminate waste and toxins from their blood. Hemodialysis takes on the work of the kidneys by pumping blood through an external circuit that filters out toxic substances and returns cleansed blood to the body. To connect the dialysis machine for treatment, patients often have a prosthetic graft in place in one of their limbs – essentially a synthetic tube that connects an artery to a vein. Blood continually flows from the artery to the vein through the prosthetic graft, allowing needles to be simply placed into the graft through the skin when the patient undergoes dialysis, usually multiple times per week.

The most common cause of graft failure is the accumulation of proliferating smooth muscle cells around the site where the graft is implanted. Many researchers have attempted to solve this problem over the past decades, but none have succeeded.

Cylerus, a leader in novel drug delivery approaches, developed the DEC graft to meet the challenges associated with prosthetic graft failure. The technology originated in the laboratory of Dr Stephen R. Hanson, formerly of Emory University and Oregon Health & Science University (OHSU). Cylerus has an exclusive license from OHSU pertaining to intellectual property describing the DEC technology.

The DEC is made up of two innovative components. First, the DEC graft has two layers – an outer cuff that contacts the graft material and an inner reservoir that fills with drug, which then enters the blood stream through pores in the device. Second, a small drug-filled pump, placed under the skin, provides the DEC with a continuous low dose of sirolimus – a well-known anti-proliferative drug.

Sirolimus prevents smooth muscle cells from accumulating around the graft, thus dramatically decreasing chances of graft failure due to obstruction of blood flow. Since an extremely low dose of sirolimus (1–2 mg/month) is delivered locally to the graft site, sirolimus blood levels never reach harmful concentrations.

“The novel DEC technology allows distribution of drug directly to the inner walls of prosthetic vascular grafts, delivering the drug in a continuous and circumferential manner to the downstream trouble areas,” explains Dr Ronald J. Shebuski, Cylerus President and CEO.

The Company has recently received Phase II SBIR fast track grant funding from the National Institute on Aging (NIA), a Division of the National Institutes of Health (NIH), to continue the development of the DEC graft into a commercially viable product. Patients with serious kidney conditions requiring chronic hemodialysis could soon have access to the DEC graft as an alternative to older unmodified prosthetic grafts.

Cylerus also notes that this technology could be adapted to a wide range of medical scenarios where the steady, localized delivery of a drug would be beneficial. “Essentially, any drug or agent could be delivered by the DEC as long as it is stable at body temperature and has a safe and effective drug dosage and formulation appropriate to the condition under study,” says Shebuski.