[February 23, 2015]

Modification of Atherosclerotic Plaque with Diamondback 360® Orbital Atherectomy Device Improves Drug Uptake in Peripheral Arteries

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 absorption in calcified peripheral arteries. Results of this ongoing study were presented by Elazer Edelman (News - Alert), M.D., Ph.D., Chairman and co-founder of CBSET, on Sunday in a dedicated session on New Strategies for the Treatment of Calcified Lesions at the "CRT 2015" annual scientific meeting in Washington, D.C.

Click here for CBSET Press Kit

"This study presents important mechanistic findings that may contribute to the expansion of endovascular intervention for PAD treatment in femoropopliteal and tibioperoneal vessels," said Dr. Edelman, who presented the study's results. "Multiple factors limit clinical benefits of drug-coated balloons (DCB) in treating peripheral atherosclerosis, including the range of constituent elements in the plaque. It has been hypothesized that drug transfer by DCB is impeded by the mature plaque morphology and can be improved by primary lesion treatment with orbital atherectomy. The results of our study support this hypothesis and illustrate that benign lesion modification with the Diamondback 360® orbital atherectomy device may greatly improve paclitaxel delivery in human peripheral arteries with calcified plaque burdens."

"A more sophisticated understanding of drug transfer after plaque modification is essential 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 (News - Alert) and collaborating companies to leverage benchtop, animal and computational studies to define the barriers to drug distribution in healthy and diseased arteries," explained Dr. Rami Tzafriri, principal scientist at CBSET. "While these initial findings illustrate, for the first time, the barrier effects of calcified plaque on arterial drug diffusion, they providea 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 these studies and the services provided by CBSET, please contact: Dr. Erica Smith, Director, Business Development: +1-781-296-5319, [email protected]

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 (News - Alert) 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.

About Cardiovascular Systems, Inc. ("CSI")

Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical device company focused on developing and commercializing innovative solutions for treating vascular and coronary disease. The company's Orbital Atherectomy Systems treat calcified and fibrotic plaque in arterial vessels throughout the leg and heart in a few minutes of treatment time, and address many of the limitations associated with existing surgical, catheter and pharmacological treatment alternatives. The U.S. FDA granted 510(k) clearance for the use of the Diamondback Orbital Atherectomy System in peripheral arteries in August 2007. In October 2013, the company received FDA approval for the use of the Diamondback Orbital Atherectomy System in coronary arteries. To date, nearly 182,000 of CSI's devices have been sold to leading institutions across the United States. Click here for Cardiovascular System Inc.'s press kit.

About CBSET

CBSET - Concord Biomedical Sciences & Emerging Technologies - 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).

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