Press Release: Lesion Preparation Using Diamondback 360® Orbital Atherectomy System Enhances Paclitaxel Distribution in Calcified Peripheral Arteries: CBSET Data Published in Journal of Controlled Release

“This preclinical demonstration of the hindrance of drug distribution by calcified tissue and improved drug delivery after modification of calcified atherosclerotic plaque could have significant clinical implications.” – Michael R. Jaff*, D.O. President, Newton-Wellesley Hospital; Professor of Medicine, Harvard Medical School

LEXINGTON, Mass., September 11, 2017  — 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 (“Calcified plaque modification alters local drug delivery in the treatment of peripheral atherosclerosis”) that provide critical insights into the barrier effects of calcified plaque on drug delivery and the treatment success of adjunctive lesion preparation therapy.

These data demonstrate enhanced paclitaxel distribution in calcified human arteries after lesion treatment using the Diamondback 360® orbital atherectomy system in a cadaver model with simulated flow and are published online in the Journal of Controlled Release.

“These data suggest that clinical association of diminished efficacy of anti-restenotic drugs in severely calcified arteries is at least partly due to limitations in drug absorption,” said Michael R. Jaff, D.O., President, Newton-Wellesley Hospital, and Professor of Medicine, Harvard Medical School.

“The data are exciting in that they suggest that subtle modification to the plaque surface can have profound effects on drug penetration. Massive debulking may be a relic of the past, and a more muted approach may extend endovascular intervention for PAD treatment into vessels even below the knee,” said Elazer Edelman, M.D., Ph.D., Chairman and co-founder of CBSET, and senior author of the paper. “This paradigm shift, which relies on quantitative studies, creates an opportunity for the medical device industry to optimize drug delivery therapies to complex lesions.”

“CBSET is committed to the development of novel experimental and computational models for defining the barrier effects of tissue components on drugs of interest and evaluating novel endovascular therapies,” explained Rami Tzafriri, Ph.D., Director of Research and Innovation at CBSET and first author of the paper. “Quantification of the barrier effects of calcified plaque through computational modeling of arterial drug distribution experiments provides a framework by which to evaluate and optimize a range of emerging drug delivery and lesion preparation therapies for peripheral artery disease.”

To learn more about this study and related services provided by CBSET or set an appointment to meet at “VIVA 2017“, please contact: Rami Tzafriri, Ph.D., Director, Research and Innovation

About Peripheral Artery Disease (PAD)

In Europe and North America, an estimated 27 million individuals are affected with PAD, which is caused by the accumulation of plaque in peripheral arteries (commonly the pelvis or leg) reducing blood flow. Left untreated, PAD can lead to severe pain, immobility, non-healing wounds and eventually limb amputation. With risk factors such as diabetes and obesity on the rise, the prevalence of PAD is growing at double-digit rates. Millions of patients with PAD may benefit from treatment with orbital atherectomy utilizing CSI’s Peripheral Orbital Atherectomy Systems, minimally invasive catheter systems developed and manufactured by CSI. These systems use a diamond-coated crown, attached to an orbiting shaft, which targets atherosclerotic plaque while preserving healthy vessel tissue — a critical factor in preventing reoccurrences. Balloon angioplasty and stents have significant shortcomings in treating hard, calcified lesions. Stents are prone to fractures and high recurrence rates, and treatment of hard, calcified lesions often leads to vessel damage and suboptimal results.


CBSET Inc. — 500 Shire Way, Lexington, MA 02421 — is a preclinical research leader in endovascular and interventional cardiology, renal disease and dialysis, 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 facility near Boston that includes a vivarium, catheterization/imaging labs, surgical suites, dedicated labs for SEM, histopathology/pathology, and drug metabolism and pharmacokinetics. CBSET offers the latest equipment for fluoroscopy, echocardiography (TEE/TTE), electrophysiology, IVUS, optical coherence tomography (OCT), endoscopy/laparoscopy, surgical video recording, histology, microradiography, and SEM (Scanning Electron Microscopy). Learn more about CBSET’s expert preclinical research services, or please  contact us.

*Dr. Jaff has no formal financial relationship with CSI or CBSET.