Modification of Atherosclerotic Plaque with Diamondback 360 Orbital Atherectomy Device Improved Drug Uptake in Peripheral Arteries in a Preclinical Study

ST. PAUL, Minn. & WASHINGTON--()--Cardiovascular Systems, Inc. (CSI) (NASDAQ:CSII), today announced that CBSET, a not-for-profit preclinical research institute dedicated to biomedical research, education, and advancement of medical technologies, disclosed that modification of atherosclerotic plaque with CSI’s Diamondback 360® orbital atherectomy device improved paclitaxel absorption by 50 percent in calcified cadavaric peripheral arteries. Historically, plaque barriers in arteries have been reported to make drug diffusion and retention more difficult.

“We are encouraged by the continued study of CSI’s unique orbital atherectomy mechanism of action and how it can help facilitate improved drug absorption and patient outcomes when calcium is present.”

Results from this ongoing preclinical study were presented by Elazer Edelman, M.D., Ph.D., Chairman and co-founder of CBSET, on Sunday, February 22, 2015, in a dedicated session on New Strategies for the Treatment of Calcified Lesions at the 2015 Cardiovascular Research Technologies (CRT) conference in Washington, D.C.

Said Dr. Edelman, “This study presents important mechanistic findings that may contribute to the expansion of endovascular intervention for PAD treatment in femoropopliteal and tibioperoneal vessels. It has been hypothesized that drug transfer by DCB is impeded by the mature plaque morphology and may be improved by primary lesion treatment with orbital atherectomy. The results of our study demonstrated that benign lesion modification with CSI’s orbital atherectomy device improved paclitaxel delivery in human cadaver peripheral arteries with substantial calcified plaque burdens.”

David L. Martin, President and Chief Executive Officer of Cardiovascular Systems, Inc., said, “We are encouraged by the continued study of CSI’s unique orbital atherectomy mechanism of action and how it can help facilitate improved drug absorption and patient outcomes when calcium is present.”

About Peripheral Artery Disease

As many as 18 million Americans, most over age 65, suffer from PAD, which is caused by the accumulation of plaque in peripheral arteries (commonly the pelvis or leg) reducing blood flow. Symptoms include leg pain when walking or at rest. 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 the Stealth 360 and Diamondback 360 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 sands away 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 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).

About Cardiovascular Systems, Inc.

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. For more information, visit the company’s website at www.csi360.com.

Product Disclosures

Peripheral Products

The Stealth 360® PAD System and Diamondback 360® PAD System are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and stenotic material from artificial arteriovenous dialysis fistulae. The systems are contraindicated for use in coronary arteries, bypass grafts, stents or where thrombus or dissections are present. Although the incidence of adverse events is rare, potential events that can occur with atherectomy include: pain, hypotension, CVA/TIA, death, dissection, perforation, distal embolization, thrombus formation, hematuria, abrupt or acute vessel closure, or arterial spasm.

Contraindications: The OAS is contraindicated when the ViperWire guide wire cannot pass across the coronary lesion or the target lesion is within a bypass graft or stent. The OAS is contraindicated when the patient is not an appropriate candidate for bypass surgery, angioplasty, or atherectomy therapy, or has angiographic evidence of thrombus, or has only one open vessel, or has angiographic evidence of significant dissection at the treatment site and for women who are pregnant or children.

Warnings/Precautions: Performing treatment in excessively tortuous vessels or bifurcations may result in vessel damage; The OAS was only evaluated in severely calcified lesions, A temporary pacing lead may be necessary when treating lesions in the right coronary and circumflex arteries; On-site surgical back-up should be included as a clinical consideration; Use in patients with an ejection fraction (EF) of less than 25% has not been evaluated. See the instructions for use before performing Diamondback 360 Coronary OAS procedures for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information call CSI at 1-877-274-0901 and/or consult CSI’s website at www.csi360.com.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Contacts

Cardiovascular Systems, Inc.
Jack Nielsen, 651-202-4919
j.nielsen@csi360.com
or
PadillaCRT
Matt Sullivan, 612-455-1709
matt.sullivan@padillacrt.com

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