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Cardiovascular Systems Peripheral and Coronary Data Featured at EuroPCR 2015Cardiovascular Systems, Inc. (CSI (News - Alert)) (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 (News - Alert), 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 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.
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Product Disclosures 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 (News - Alert), death, dissection, perforation, distal embolization, thrombus formation, hematuria, abrupt or acute vessel closure, or arterial spasm. The Diamondback 360ยบ 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.
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