Press Release: Primary lesion treatment using Diamondback 360® orbital atherectomy system enhances paclitaxel deposition in calcified peripheral arteries: preclinical data presented at EuroPCR 2015

““This preclinical study could have a significant clinical impact by demonstrating improved drug delivery after modification of calcified lesions,” said Gunnar Tepe, M.D., RoMed Hospital, Rosenheim, Germany.

LEXINGTON, Mass., May 20, 2015 — CBSET, a not-for-profit preclinical research institute dedicated to biomedical research, education, and advancement of medical technologies, disclosed today that modification of atherosclerotic plaque with the Diamondback 360® orbital atherectomy device (Cardiovascular Systems, Inc.) improved drug uptake in calcified peripheral lesions from human cadavers. Results of this study (“Primary lesion treatment with an orbital atherectomy system enhances paclitaxel deposition in calcified peripheral arteries”) were presented yesterday by Elazer Edelman, M.D., Ph.D., Chairman and co-founder of CBSET, in a dedicated session, “Peripheral interventions”, at the “EuroPCR 2015” annual scientific meeting in Paris.

“We know from clinical studies that anti-restenotic drug effects are diminished in severely calcified arteries,” said Gunnar Tepe, M.D., RoMed Hospital, Rosenheim, Germany.

“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 a co-author of the study, added,

“A more sophisticated understanding of drug transfer after plaque modification is critically important to optimizing PAD therapies for improved clinical outcomes,” said Peter Markham, President, CEO and a co-founder of CBSET.

“This study is part of a larger effort by CBSET, MIT and collaborating companies to leverage benchtop, animal, and computational studies in order to define the barriers to drug distribution in healthy and diseased arteries,” explained Rami Tzafriri, Ph.D., principal scientist at CBSET. “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.”

To learn more about this study and the services provided by CBSET, please contact: Erica Smith, Ph.D., Director, Business Development: +1-781-296-5319,

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 — 500 Shire Way, Lexington, MA 02421 — is the preclinical research leader in critically important therapeutic fields such as 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).