Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), will present six-month data from the COMPLIANCE 360° study of severely calcified above-the-knee lesions at the 23 rd Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco, sponsored by the Cardiovascular Research Foundation, on November 8, 2011.

COMPLIANCE 360° is a prospective multi-center study comparing treatment using CSI’s Diamondback 360° device versus percutaneous transluminal angioplasty (PTA). Dr. Raymond Dattilo, St. Francis Health Center, Topeka, Kan., principal investigator of the COMPLIANCE 360° study, will present his findings in an oral presentation on Tuesday, November 8. (Oral presentation No. 93, Moscone Center Room 112, 10:15 a.m.-12:30 p.m.)

“CSI is committed to amassing clinical data on our technology to help physicians make sound treatment decisions for their patients. We look forward to presenting results from six different studies next week at TCT,” said David L. Martin, CSI president and chief executive officer.

Along with COMPLIANCE 360° results, data from several additional studies will be highlighted during TCT poster sessions.

Peripheral Arterial Disease Clinical Study Results

Three studies will focus on results for treatment of peripheral arterial disease (PAD), or blockages in leg arteries.
  • Six-Month Outcomes of Prospective, Randomized CALCIUM 360° Study Demonstrate the Advantages of Plaque Modification with the Orbital Technology Versus Treatment with Balloon Angioplasty in Patients with Critical Limb Ischemia, presented by Dr. Nicolas W. Shammas, Trinity Medical Center, Bettendorf, Iowa. (Poster No. 570, Moscone Center Hall D, 8-10 a.m.)

CALCIUM 360° is a prospective, multi-center randomized study comparing treatment of below-the-knee lesions with the Diamondback 360° versus percutaneous transluminal angioplasty.
  • CONFIRM II Predator data, presented by Dr. Gaurav Aggarwala, Utah Cardiology, Layton, Utah. (Poster No. 560, Moscone Center Hall D, 8-10 a.m.)

CONFIRM II Predator is a prospective registry of 1,127 patients treated with the Predator 360°, collected by 153 investigators at 122 institutions. The study is designed to determine device utility and procedural success in a real-world patient population.
  • Use of Orbital Treatment in a High Volume Clinical Practice Modifies Non-Compliant Plaque to Deliver Durable Long-Term Results, presented by Dr. Prakash Makam, Community Hospital, Munster, Ind. (Poster No. 576, Moscone Center Hall D, 8-10 a.m.)

Dr. Makam will report on a single-center study of 46 patients with fibrotic or calcified lesions who were treated with the Predator 360°.

Coronary Arterial Disease Clinical Study Results

Two poster presentations by Dr. Keyur Parikh, Care Institute of Medical Science, Ahmedabad, India, will review data from ORBIT I, a feasibility study for a coronary application using CSI’s orbital mechanism of action.
  • Six-Month Follow up Data of Orbital Atherectomy System for the Treatment of De Novo Calcified Coronary Lesions (Poster No. 643, Moscone Center Hall D, 8-10 a.m.)
  • Two-Year Follow up Data of Orbital Atherectomy System for the Treatment of De Novo Calcified Coronary Lesions – A Single Center Experience (Poster No. 647, Moscone Center Hall D, 8-10 a.m.)

About Peripheral Arterial DiseaseAs many as 12 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 the Stealth 360°, Predator 360°, or Diamondback 360⁰ devices, minimally invasive catheter systems developed and manufactured by CSI. These systems use a diamond-coated crown, attached to a guide wire, which sands away plaque while preserving healthy vessel tissue, or medial integrity — 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 CRF and TCTThe Cardiovascular Research Foundation (CRF) is an independent, academically focused nonprofit organization dedicated to improving the survival and quality of life for people with cardiovascular disease through research and education. Since its inception in 1991, CRF has played a major role in realizing dramatic improvements in the lives of countless numbers of patients by establishing the safe use of new technologies, drugs, and therapies in the subspecialty of interventional cardiology and endovascular medicine.

Transcatheter Cardiovascular Therapeutics (TCT) is the annual scientific symposium of the Cardiovascular Research Foundation. TCT gathers leading medical researchers and clinicians from around the world to present and discuss the latest developments in the field.For more information, visit www.crf.org.

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 Stealth 360 °TM, Diamondback 360 ® and Predator 360 ® PAD Systems treat calcified and fibrotic plaque in arterial vessels throughout the leg 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 360° in August 2007, the Predator 360° in March 2009 and for the Stealth 360° in March 2011. To date, more than 55,000 PAD procedures have been performed using CSI's PAD systems 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.

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

Product DisclosureThe Stealth 360 °TM, Diamondback 360 ® and Predator 360 ® PAD Systems 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.

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