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.)
- CONFIRM II Predator data, presented by Dr. Gaurav Aggarwala, Utah Cardiology, Layton, Utah. (Poster No. 560, Moscone Center Hall D, 8-10 a.m.)
- 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.)
Coronary Arterial Disease Clinical Study ResultsTwo 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.)
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.