Prominent Physicians to Present New Arterial Calcification Research at 2013 TCT Conference Building on PAD Expertise, CSI Secures Coronary Approval; TCT Events to Address Complexities of Calcification in both PAD and CAD Business Wire ST. PAUL, Minn. -- October 23, 2013 Cardiovascular Systems, Inc. (CSI) (NASDAQ:CSII), announced today that new data about the treatment of arterial calcification will be unveiled at the 2013 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco, Oct. 27–Nov. 1, 2013. Arterial calcium is a common occurrence for the millions of patients suffering from peripheral artery disease (PAD) and coronary artery disease (CAD), and it can lead to significant complications. Calcified plaque is estimated to be present in approximately 65 percent of the population treated annually for PAD. CSI’s Peripheral Orbital Atherectomy System (OAS) contains a proprietary platform technology that provides clinical benefits, and its centrifugal force allows for treatment of a broad range of arterial vessel diameters. It also offers differential sanding with a unique orbital crown, which reduces complications. Visitors to CSI’s booth at TCT can view interactive, virtual demonstrations of the device and learn how to treat atherosclerotic tissues, including calcified plaque. The Stealth 360^® now features an all new prime button that allows for quick flushing, an added measure of control for physicians. CSI Secures Coronary Approval The company’s TCT’s events follow CSI’s recent coronary approval. On Oct. 21, CSI received Premarket Application (PMA) approval from the U.S. Food and Drug Administration (FDA) to market its Diamondback 360^® Coronary Orbital Atherectomy System as a treatment for severely calcified coronary arteries. 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 substantially higher occurrence of death and major adverse cardiac events (MACE). This approval opens up a large, underserved U.S. market opportunity for CSI, estimated to exceed $1.5 billion annually. CSI began a controlled commercial launch of its Diamondback 360 Coronary OAS immediately following FDA approval. Peripheral Presentations at TCT Oral Presentation Dr. Lawrence Garcia, St. Elizabeth’s Medical Center, Boston, will WHAT: present “The Data-Driven Role of Atherectomy in SFA Disease Today and Tomorrow: LIBERTY 360 and the JET Registry.” WHEN: Sunday, Oct. 27, 1:12 p.m. WHERE: Moscone Center West Room 2020 800 Howard Street San Francisco, CA 94103 Poster Presentations “Sub-analysis of the CONFIRM Registries: Outcomes in Claudicant WHAT: Patients Treated for Peripheral Arterial Disease with Orbital Atherectomy,” presented by Dr. George L. Adams “Pooled Analysis of the CONFIRM Registries: Outcomes in Elderly Patients Treated with Orbital Atherectomy for Peripheral Arterial Disease,” presented by Dr. Michael S. Lee “Pooled Analysis of the CONFIRM Registries: Outcomes in Critical Limb Ischemia Patients Treated for Peripheral Arterial Disease with Orbital Atherectomy,” presented by Dr. Tony Das “Pedal Arch Reconstruction Utilizing Orbital Atherectomy Challenging Case,” presented by Dr. Arthur C. Lee WHEN: Tuesday, Oct. 29, 3:30–5:30 p.m. WHERE: Moscone Center West Building 1^st floor 800 Howard Street San Francisco, CA 94103 Coronary Presentations at TCT Oral Presentation Dr. Jeffrey Chambers, Mercy Hospital, Coon Rapids, Minn., will WHAT: present “Evaluation of Utility and Efficacy of Orbital Atherectomy to Treat Severely Calcified Lesions: ORBIT II.” WHEN: Monday, Oct. 28, 5:56 p.m. WHERE: Moscone Center West Room 2007 800 Howard Street San Francisco, CA 94103 Poster Presentations “Predictors of Stent Expansion After Drug-eluting Stents: An WHAT: ADAPT-DES IVUS Substudy,” presented by Dr. Nobuaki Kobayashi, Dr. Gary S. Mintz and Dr. Gregg W. Stone “Relationship Between Renal Function and Lesion Morphology: An ADAPT-DES VH-IVUS Substudy,” presented by Dr. Shigeo Saito, Dr. Gary S. Mintz and Dr. Gregg W. Stone WHEN: Tuesday, Oct. 29, 3:30–5:30 p.m. WHERE: Moscone Center West Building 1^st floor 800 Howard Street San Francisco, CA 94103 Sponsored Evening Sessions at TCT Two evening sessions at TCT will explore topics regarding coronary calcification and below-the-knee (BTK) intervention. These symposia are sponsored by Cardiovascular Research Foundation, supported through an educational grant from Cardiovascular Systems, Inc. “Coronary Calcification: Between a Rock and a Hard WHAT: Place,” chaired by Dr. Gregg W. Stone and Dr. Maurice Buchbinder WHEN: Tuesday, Oct. 29, 7–8:30 p.m. WHERE: Moscone Center West Room 2014–2018 800 Howard Street San Francisco, CA 94103 “A Deep Dive on BTK Intervention: Strategy Technique and WHAT: Emerging Therapeutic Devices,” chaired by Dr. Juan F. Granada, Dr. William A. Gray, Dr. Barry T. Katzen and Dr. Jihad A. Mustapha WHEN: Thursday, Oct. 31, 7–8:30 p.m. WHERE: Moscone Center West Room 2002–2006 800 Howard Street San Francisco, CA 94103 CSI Booth at TCT: Oct. 27–31 Visit CSI at booth #529, 5–7 p.m., Tuesday, Oct. 29, and 9 a.m.–5 p.m., Wednesday, Oct. 30, and Thursday, Oct. 31, to meet the company’s calcium experts and learn more about CSI’s orbital technology. About Peripheral Arterial Disease PAD is a life-threatening condition where a fatty material called plaque builds up on the inside walls of the blood vessels that carry blood from the heart to legs and arms. The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow to the legs. The risk of PAD increases if a person has one or several of the following: high blood pressure, abnormal cholesterol levels, diabetes, or personal history of heart disease, heart attack or stroke. PAD affects an estimated 8-12 million people in the United States. The disease prevalence increases with age and 12-20 percent of Americans age 65 and older suffer from PAD symptoms. As the U.S. population ages, the prevalence range could reach 16 million in those age 65 and older and 19 million overall by 2050. About Coronary Arterial Disease Coronary Artery Disease (CAD) is a life-threatening condition and 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. CAD affects an estimated 16.8 million people in the United States and is the most common form of heart disease. Heart disease claims more than 600,000 lives, or 1 in 4 Americans, in the United States each year. 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 System is a platform technology for the treatment of calcified fibrotic plaque in arterial vessels. In August 2007, the FDA originally granted CSI’s first OAS device 510(k) clearance for the use of the Diamondback Peripheral Orbital Atherectomy System. To date, nearly 120,000 of CSI’s peripheral devices have been sold to leading institutions across the United States CSI has recently been granted approval by the FDA for the Diamondback 360^® Coronary OAS, another revolutionary step toward treating calcified lesions. Cardiovascular Systems, Inc. For more information, visit the company’s website at www.csi360.com. Coronary Product Disclosure 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. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. Contact: Cardiovascular Systems, Inc. Investor Relations, 651-259-2800 firstname.lastname@example.org or Sarah Wozniak, 651-259-1636 email@example.com or PadillaCRT: Matt Sullivan, 612-455-1709 firstname.lastname@example.org or Janey Kiryluik, 612-455-1724 email@example.com
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Prominent Physicians to Present New Arterial Calcification Research at 2013 TCT Conference
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