ST. PAUL, Minn. & ORLANDO, Fla.--(BUSINESS WIRE)--Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), a medical device company developing and commercializing innovative interventional treatment systems for vascular disease, today announced that five abstracts focusing on advances in the treatment of Peripheral Arterial Disease (PAD) and Coronary Arterial Disease (CAD) will be presented at the upcoming C3 Conference (Complex Cardiovascular Catheter). The abstracts will highlight data from CSI trials focused on the clinical and economic benefits of using its Orbital Atherectomy technology to treat patients with calcified lesions. The conference is taking place June 19–23 in Orlando, Fla.
The five abstracts are:
Three Year Outcome of Orbital Atherectomy Calcified Lesions: ORBIT I Three Year Outcome
Focus: The ORBIT I trial was conducted to evaluate the safety and performance of the Diamondback 360® Orbital Atherectomy System (OAS) for the treatment of calcified coronary lesions. Three-year single center data from 33 patients will be presented by Dr. Milan Chag – Care Institute of Medical Sciences, Ahmedabad, Gujarat, India (Wed., June 20, 4:30–4:40 p.m.)
CONFIRM Series I & II: Treatment Outcome of Nearly 2,000 Patients with Calcified Peripheral Arteries Treated with Two Designs of the Orbital PAD System
Focus: The CONFIRM I and II registries were conducted prospectively at over 200 sites in the U.S. (1,860 patients/2,880 lesions) under a common protocol to evaluate the success of orbital PAD in plaque modification in real-world patients with calcified infra-inguinal disease. No exclusion criteria were applied. Completion of these two studies provides extensive experience and consistent, repeatable procedural results that may be an indicator of improved long-term outcome and durability. Presented by Raymond Dattilo, MD – St. Francis Health Center, Topeka, Kan. (Wed., June 20, 5–5:10 p.m.)
CALCIUM 360º 12-Month Data
Focus: Presentation of a prospective multicenter study evaluating short- and long-term outcomes in 50 patients with severely calcified lesions randomized, 1:1, to Diamondback 360 Orbital Atherectomy System followed by low pressure balloon angioplasty (POBA), versus POBA alone. Presented by Jihad Mustapha, MD – Metro Health Hospital, Wyoming, Mich. (Wed., June 20, 5:10–5:20 p.m.)
Use of Orbital Atherectomy System in an Office-Based Laboratory versus Hospital Settings
Focus: Limited data exists evaluating varied technologies used in office-based endovascular suite or office-based laboratory (OBL) settings. This analysis of orbital atherectomy was conducted to determine whether outcomes in safety and procedural success could be maintained in outpatient OBL settings compared to traditional hospital settings when matched for similar patient demographics. Presented by Guy Mayeda, MD – Los Angeles Cardiology Associates, Los Angeles (Wed., June 20, 5:20–5:30 p.m.)
Expected Outcomes and Hospital Costs Associated with Percutaneous Coronary Intervention (PCI) and Atherectomy in Treatment of Moderate to Severely Calcified Coronary Lesions
Focus: Analysis examining the expected outcomes and hospital costs associated with PCI plus stent versus atherectomy plus stent in the treatment of moderately to severely calcified coronary lesions. Presented by Richard Schlofmitz, MD – St. Francis Hospital, Roslyn, NY (Sat., June 23, 11–11:15 a.m.)
ABOUT PAD: 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 estimate 8-12 million in the United States. The disease prevalence increases with age and 12-20 percent of Americans age 65 and older (4.5 to 7.6 million) suffer from PAD symptoms. As the U.S. population ages, the prevalence range could reach 9.6 to 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 Diamondback Orbital Atherectomy System treats 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, more than 66,000 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.
For more information, visit the company’s website at www.csi360.com.