ST. PAUL, Minn.--(BUSINESS WIRE)--Oct 3, 2012--Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), will present data from its CONFIRM study series at the 10 th annual VIVA conference in Las Vegas, Oct. 9–11, 2012. The CONFIRM study series evaluated the safety and procedural effectiveness of CSI’s orbital atherectomy system as a treatment for above- and below-the-knee calcified lesions. CONFIRM is one of CSI’s many studies undertaken to provide physicians with scientific data to make sound treatment decisions. To date, over 70,000 PAD procedures have been performed using CSI’s technology in leading institutions across the United States.
VIVA Late-Breaking Trial Results Presentation: Oct. 10 WHAT: Dr. Tony Das, Cardiology and Interventional Associates, Dallas, Texas, a significant contributor to the execution and analysis of the CONFIRM series, will present the late-breaking results.
The CONFIRM series consisted of three real-world studies from 2009 to 2011 that used CSI’s orbital atherectomy systems to treat more than 3,100 patients (4,700 lesions), most with moderate to severe calcium. CSI’s orbital atherectomy system is minimally invasive and indicated for use as therapy in patients with peripheral arterial disease (PAD) – blockages in leg arteries.
WHEN: Wednesday, Oct. 10, 3:16 p.m. WHERE: Lafite Ballroom, Wynn Las Vegas 3131 Las Vegas Blvd. S. Las Vegas, NV 89109 CSI-Sponsored Lunch Symposium: Oct. 11 WHAT: Industry leaders will share their expertise on topics associated with PAD during a lunch symposium hosted by CSI. The symposium, titled “PAD Present and Future: The Evolution Toward Orbital Atherectomy,” will cover calcium complications in PAD patients, stenting implications to consider for below-the-knee PAD cases, simple techniques for treating patients with critical limb ischemia, and considerations when using orbital atherectomy in an office-based lab setting. The symposium will be moderated by Michael R. Jaff, DO, Massachusetts General Hospital, Boston, Mass.
TOPICS: -- Calcium: One of PAD’s Greatest Challenges William A. Gray, MD, Center for Interventional Vascular Therapy, New York, N.Y.
-- BTK Cases: To Stent or Not to Stent George L. Adams, MD, UNC Healthcare, Chapel Hill, N.C.
-- CLI Treatment: Simple Tips and Techniques Jihad A. Mustapha, MD, Metro Health Hospital, Wyoming, Mich.
-- OAS for OBL George A. Pliagas, MD, St. Mary’s Medical Center, Knoxville, Tenn.
-- Panel Discussion WHEN: Thursday, Oct. 11, noon – 1 p.m. WHERE: Petrus 2, Wynn Las Vegas 3131 Las Vegas Blvd. S. Las Vegas, NV 89109 CSI Launches CSIQ: Oct. 11 WHAT: CSI will launch its enhanced medical education program, CSIQ, at VIVA. CSIQ includes comprehensive courses taught by leading orbital atherectomy experts. The courses consist of personalized one-on-one proctorships, fundamental and advanced preceptorships, and national symposia. As a new element of CSIQ, CSI will host a hands-on cadaver lab at VIVA, featuring ultrasound guided tibial and pedal access followed by orbital atherectomy treatment. Doctors Jihad Mustapha (IC), Robert Vorhies (VS) and Warren Swee (IR) are the instructors.
WHEN: Thursday, Oct. 11, 5:45 – 8:45 p.m. WHERE: Mobile Lab, Wynn Las Vegas 3131 Las Vegas Blvd. S. Las Vegas, NV 89109 CSI Booth at VIVA: Oct. 9 – 11 Visit CSI at booth #106, 7:00 a.m. – 4 p.m., Tuesday, Oct. 9 and 7:30 a.m. – 4 p.m. Wednesday, Oct. 10; and 9:30 a.m. – 4 p.m. on Thursday, Oct. 11.
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 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 in a few minutes of treatment time, and addresses 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 August 2007. To date, over 70,000 PAD procedures have been performed using CSI’s technology in leading institutions across the United States. CSI has also commenced its ORBIT II Investigational Device Exemption clinical trial to evaluate the safety and effectiveness of its orbital technology in treating coronary arteries. The coronary system is limited by federal law to investigational use and is currently not commercially available in the United States.
Product Disclosure The Stealth 360° ® PAD System, Diamondback 360 ® PAD System and Predator 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.
For more information, visit the company’s website at www.csi360.com.CONTACT: Cardiovascular Systems, Inc.
Matt Sullivan, 612-455-1709 firstname.lastname@example.org or Dave Folkens, 612-455-1741 email@example.com KEYWORD: UNITED STATES NORTH AMERICA MINNESOTA NEVADA INDUSTRY KEYWORD: SURGERY PRACTICE MANAGEMENT HEALTH CARDIOLOGY CLINICAL TRIALS HOSPITALS MEDICAL DEVICES MANAGED CARE SOURCE: Cardiovascular Systems, Inc. Copyright Business Wire 2012 PUB: 10/03/2012 02:27 PM/DISC: 10/03/2012 02:27 PM http://www.businesswire.com/news/home/20121003006417/