CBSET said its study’s results confirm a new paradigm for optimizing coating biocompatibility.
CBSET, a not-for-profit preclinical research institute dedicated to biomedical research, education, and advancement of medical technologies, recently announced that its scientists have published data and analyses (“Sustained Efficacy and Arterial Drug Retention by a Fast Drug-Eluting, Cross-Linked Fatty Acid Coronary Stent Coating”) which “suggest a new paradigm whereby the safety of drug eluting stents can be optimized through the use of resorbable biocompatible coating materials with resorption kinetics that coincide with the dissociation and tissue elimination of receptor-bound drug.” The study is published online by Annals of Biomedical Engineering, a publication of the Biomedical Engineering Society (BMES).
“The conventional wisdom – that sustained drug elution from stent coatings over the course of weeks or months is required for clinical efficacy – has dramatically restricted the options for stent coating materials,” said Dr. Tzafriri, co-first author on the paper. “Based on these data, we can assert that this presumption is no longer true.”
”We hypothesized that receptor-mediated drug retention provides a mechanism by which stent coating compositions that degrade rapidly can still deliver controlled volumes of drug without loss of biological effect and at reduced periods of tissue vulnerability,” said Dr. Natalie Artzi, assistant professor at the department of Medicine, Brigham and Women’s Hospital, and a researcher at the Institute for Medical Engineering and Science at MIT, and co-first author of the paper.
“We developed and evaluated a cross-linked omega-3 fatty acid (O3FA)-based coating that is 85 percent absorbed and elutes 97 percent of its Sirolimus analog (Corolimus) load within eight days of implantation. This fast absorption allows for implanted stent struts to be quickly endothelialized, thereby reducing the risk of late stent thrombosis with minimal and stabilizing late-lumen loss,” said Dr. Keith Faucher, co-author and Director of Research and Analytical Chemistry at MAQUET Vascular Systems (formally Atrium Medical Corporation).
“This study represents a significant medical milestone in the ongoing development of therapies to treat coronary artery disease,” added Elazer Edelman, M.D., Ph.D., chairman and co-founder of CBSET, and senior author of the paper. “Now, the composition of Sirloimus-eluting stent (SES) coatings can be designed for optimal biocompatibility and bioabsorption rather than drug-elution alone,” said Dr. Edelman. “This paradigm shift creates an opportunity for the pharmaceutical and medical technology industries to use a range of biocompatible materials that may not have otherwise been considered.”
In addition to being published in the latest issue of Annals of Biomedical Engineering, the study results were presented by Dr. Tzafriri at the scientific workshop, “Next-Generation Medical Stents: Scoping the Future.” (Sept. 4 at the University of Limerick, Ireland.)
CBSET
www.cbset.org
