Press Release: Study Validates New Approach for Optimizing Endovascular Drug Delivery Using Stents with a Deployable Coating That Enhances Sirolimus Distribution Compared to Traditional DES

“Defining drug and target protein distributions after stent-based drug release: Durable versus deployable coatings” published online in Journal of Controlled Release

“This preclinical demonstration of the enhanced and more uniform drug and biomarker distribution by stents with deployable coatings could lead to more rapid and improved healing after stent implantation,” said David Kandzari, M.D., Director of Interventional Cardiology and Chief Scientific Officer, Piedmont Heart Institute, Atlanta.

LEXINGTON, Mass., Feb. 22, 2018 – CBSET Inc., a not-for-profit preclinical research institute dedicated to translational research, education, and advancement of medical technologies, announced today that its scientists have published data and analyses (“Defining drug and target protein distributions after stent-based drug release: Durable versus deployable coatings”) that provide critical insights into the tissue distribution patterns of antiproliferative drugs released from stents for treatment of coronary artery disease. The study is published online in the Journal of Controlled Release.

“The frustration is that stent designs that release similar drugs from a conformal coating are increasingly difficult to differentiate using tissue growth metrics in animal models or clinical metrics in humans. It is only through reassessment of the role of each design parameter that we can hope to achieve disruptive innovations. To support such innovations, we developed an immunofluorescent method that simultaneously tracks the distribution of drug and its intracellular binding proteins within stented arteries,” said Rami Tzafriri, Ph.D., Director of Research and Innovation at CBSET and first author of the paper. “Using these methods we demonstrated that deployment of drug microcrystals using an absorbable coating resulted in spatially and temporally more uniform drug delivery compared to traditional durable coated stents.”

“Innovations in device design and preclinical models go hand-in-hand, as one enables the other. Early developments in bare and drug-eluting stents have taught us much about vascular biology, yet further innovation in stent design has been hampered by preclinical models that could not determine much more than bulk tissue content and are limited in their ability to distinguish drug distribution for competing device designs. The coupling of immunofluorescence on tissue sections and computational modeling with an understanding of the vascular response to device implantation is an important step toward filling this void. We can now differentiate DES and drug-eluting systems based not simply on payload or time of release but on net tissue spatial delivery. In doing so, it is possible to anticipate target effects rather than focus on target stimuli,” said Elazer Edelman, M.D., Ph.D., Chairman and co-founder of CBSET, and senior author of the paper.

“This paradigm shift in preclinical assessment of stents creates an opportunity for the medical device industry to optimize endovascular drug delivery therapies to coronary and peripheral lesions,” said Peter Markham, MS, President and CEO of CBSET, and co-author of the article.

For more information about CBSET, contact Michael Naimark, Director of Business Development at CBSET: +1-781-541-5627,


CBSET Inc. — 500 Shire Way, Lexington, MA 02421 — is an established translational research leader in endovascular and interventional cardiology, renal disease models, chronic drug-resistant hypertension, women’s health, minimally invasive surgery, orthopedics, biological and synthetic tissue repair, drug delivery, bioresorbable devices, and combination medical device and drug-eluting products. CBSET occupies a 35,000-square-foot, state-of-the-art GLP-compliant facility near Boston that includes an AAALAC-accredited vivarium, catheterization/imaging suites, dedicated labs for SEM, histopathology/pathology, and provides drug metabolism and pharmacokinetics services. CBSET is a registered 501(c)3 nonprofit with a mission to provide technical, scientific, and regulatory support for novel biomedical therapies.