Data shows that vessel preparation with CSI’s orbital atherectomy system enables low-pressure adjunctive balloon angioplasty across the studies, with low procedural events and bail-out stents—which preserve treatment options in the future.Overall Procedural Outcomes:
|Per Lesion||CONFIRM I n=1,146||CONFIRM II n=1,734||CONFIRM III n=1,886|
|Mean Inflation||5.7 atms||5.4 atms||5.9 atms|
|Bail-out Stent (due to dissections)||3.8%||5.8%||5.2%|
|Orbital Atherectomy plus||PTA alone|
|Mean Inflation||5.9 atms||9.4 atms|
|Freedom from major serious adverse events||93.3%||57.9%|
CSI Poster Session at ISETDr. Barry Weinstock, Mid-Florida Cardiology Specialists, Orlando, Fla., and Dr. Raymond Dattilo (presenter), St. Francis Health Center, Topeka, Kan., presented Cost Consequences of Orbital Atherectomy Plus Angioplasty vs. Angioplasty Alone for Treatment of Calcified Femoropopliteal Lesions in a poster session at ISET.Data shows that orbital atherectomy plus balloon angioplasty has a significantly lower average stenosis rate, exhibiting compelling short- and longer-term health and economic data for the use of atherectomy in the treatment of calcified femoropopliteal lesions. About Peripheral Arterial DiseasePAD 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 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 Orbital Atherectomy System in August 2007. To date, nearly 100,000 of CSI’s devices have been sold to 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° ® 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.