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September 30, 2020

CBSET Preclinical Study Shows Balloon-Based Drug Delivery Is Critically Dependent on Coating Micromorphology

September 30, 2020—CBSET Inc., a not-for-profit translational research institute, announced the publication of a preclinical study, “Balloon-based drug coating delivery to the artery wall is dictated by coating micro-morphology and angioplasty pressure gradients,” by Abraham R. Tzafriri , PhD, et al online ahead of print in the Journal of Biomaterials.

Dr. Tzafriri, who is Director of Research and Innovation for CBSET, explained the study and the findings in the CBSET press release.

“Despite the availability of 5-year clinical studies on drug-coated balloons (DCBs), not much was known on how and where these devices deliver their drug load,” stated Dr. Tzafriri. “Unlike stents that deliver drug at predictable strut locations with predictable elution kinetics, DCBs deliver solid drug microparticles, and the mechanisms governing this were not well understood.

“To address these needs, we developed an imaging method to visualize and quantify the endoluminal distribution and micromorphology of DCB coatings and to assess their tissue embedding. Moreover, we developed a novel computational model for predicting local arterial tissue microindentation pressures exerted by coating particles during balloon expansion, allowing for correlation of imaged coating transfer gradients across the treatment zone with simulated contact pressure gradients for each of the coating morphologies. Whereas imaging demonstrated differential endoluminal distribution of flaky and microcrystalline coatings, computational modeling related these differences to the ability of the microcrystals to amplify the angioplasty pressure at the treatment site.”

CBSET’s chairman and cofounder, Elazer Edelman, MD, PhD, who is the senior author of the paper, added, “Innovations in device design and preclinical models go hand-in-hand, as one enables the other. The methods that served the industry well in developing drug-eluting stents are no longer adequate when evaluating devices that deliver coating rather than elute drug, creating a need for the introduction of new methods and concepts. The coupling of novel quantitative imaging after in vivo treatments and computational modeling of the micromechanical coating/tissue interactions is an important step toward filling this void. We can now begin to differentiate drug-coated balloons based not simply on drug payload, excipient or dissolution rate, but also on net tissue spatial delivery. In doing so, it is possible not only to accelerate preclinical development but also to anticipate disease effects as part of that process.”

Peter M. Markham, MS, President and CEO of CBSET and an investigator in the study, further noted, “Concerns about paclitaxel toxicity have created an urgent opportunity for novel device design. CBSET has spent years of investment in the development of novel preclinical methods that enable the study of drug uptake from DCBs.”

Finally, Sahil A. Parikh, MD, Director of Endovascular Services at the Columbia University College of Physicians and Surgeons in New York, New York, who is not a study investigator, commented in the CBSET announcement. “These preclinical studies transform our understanding of how [DCBs] deliver drug to the artery and why there is no class effect, while also providing tools for understanding the role of tissue stiffening with disease. The combination of mechanistic insight with predictive modeling can help accelerate development of new technologies such as those including sirolimus analogs.”

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