It seems removal or modification of mature plaque deposits in peripheral artery disease with an orbital atherectomy device improves delivery of Paclitaxel from drug coated balloon surface to vessel wall.
The theory goes that the plaque deposited in a diseased peripheral vessel may impair the effect of any drug that has been applied to the surface of a drug coated balloon, effectively blocking its transfer to vessel wall, and with that reducing it’s therapeutic effect.
Now a not-for-profit preclinical research institute, CBSET has proved the point by showing how use of a device that removes some of the plaque, Diamondback 360® orbital atherectomy device (Cardiovascular Systems, Inc.) improved drug absorption in calcified peripheral arteries.
The Cardiovascular Systems Diamondback Orbital Atherectomy System, FDA cleared for peripheral vascular use as far back as 2007, is designed for treatment of calcified and fibrotic plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time. The company says it addresses many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives.
CBSET is dedicated to biomedical research, education, and advancement of medical technologies. Results of an ongoing study by the group have been presented by Elazer Edelman, M.D., Ph.D., Chairman and co-founder of CBSET, in a dedicated session on New Strategies for the Treatment of Calcified Lesions at the “CRT 2015” annual scientific meeting in Washington, D.C.
“This study presents important mechanistic findings that may contribute to the expansion of endovascular intervention for PAD treatment in femoropopliteal and tibioperoneal vessels,” said Dr. Edelman, who presented the study’s results. “Multiple factors limit clinical benefits of drug-coated balloons (DCB) in treating peripheral atherosclerosis, including the range of constituent elements in the plaque. It has been hypothesized that drug transfer by DCB is impeded by the mature plaque morphology and can be improved by primary lesion treatment with orbital atherectomy. The results of our study support this hypothesis and illustrate that benign lesion modification with the Diamondback 360® orbital atherectomy device may greatly improve paclitaxel delivery in human peripheral arteries with calcified plaque burdens.”
Dr. Rami Tzafriri, principal scientist at CBSET stated; “While these initial findings illustrate, for the first time, the barrier effects of calcified plaque on arterial drug diffusion, they provide a path for improved therapy, as even relatively benign modification of this plaque barrier can profoundly improve drug delivery into diseased peripheral arteries.”