ST. PAUL, Minn. & PARIS--(BUSINESS WIRE)--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, presented pre-clinical study data at the 2015 European Association of Percutaneous Cardiovascular Interventions (EuroPCR) conference taking place May 19-22, 2015, in Paris, France.
Elazer Edelman, M.D., Ph.D., Chairman and co-founder of CBSET, presented data showing that primary treatment with CSI’s Diamondback 360® Orbital Atherectomy System (OAS) improved paclitaxel absorption by 50 percent in calcified cadaveric peripheral arteries. Historically, calcified plaque barriers in arteries have been reported to make drug diffusion and retention more difficult.
David L. Martin, President and Chief Executive Officer of Cardiovascular Systems, Inc., said, “We remain steadfast in our pursuit of critical and actionable clinical data. We continue to be encouraged by the ongoing study of CSI’s unique orbital atherectomy mechanism of action and how it may help facilitate improved drug absorption and peripheral patient outcomes when calcium is present. With this, we will continue to study the use of OAS as the primary treatment for arterial calcium with drug-coated-balloon therapy.”
Martin also indicated that Dr. Jeffery Chambers presented a Late-Breaking Clinical Trial Hot-line presentation on the two-year results from its ORBIT II trial at EuroPCR 2015, as well as a new two-year extrapolated economic analysis of the company’s Diamondback 360 Coronary OAS in treating severely calcified lesions. The Diamondback 360 Coronary OAS has been associated with a short length of stay for patients when the device was used to treat severely calcified lesions to facilitate stent placement. The low incidence of readmission and short length of stay provide an estimated cost savings of up to $4,946 per patient to the treating institution at two years following the procedure.
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 Coronary Artery Disease
CAD is a life-threatening
condition and a leading cause of death in men and women in the United
States. CAD occurs when a fatty material called plaque builds up on the
walls of arteries that supply blood to the heart. The plaque buildup
causes the arteries to harden and narrow (atherosclerosis), reducing
blood flow. The risk of CAD increases if a person has one or more of the
following: high blood pressure, abnormal cholesterol levels, diabetes,
or family history of early heart disease. According to the American
Heart Association, 16.3 million people in the United States have been
diagnosed with CAD, the most common form of heart disease. Heart disease
claims more than 600,000 lives in the United States each year. According
to estimates, significant arterial calcium is present in nearly 40
percent of patients undergoing a percutaneous coronary intervention
(PCI). Significant calcium contributes to poor outcomes and higher
treatment costs in coronary interventions when traditional therapies are
used, including a significantly higher occurrence of death and major
adverse cardiac events (MACE).
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 200,000 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
Stealth
360® PAD Systems and Diamondback 360®
PAD Systems Indications: 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.
Important Safety Information: 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.
The Diamondback 360º Coronary Orbital Atherectomy System
Indications: The Diamondback 360® Coronary Orbital Atherectomy System (OAS) is a percutaneous orbital atherectomy system indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.
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.
Federal law (USA) restricts these devices to sale by or on the order of a physician.