David L. Martin, CSI president and chief executive officer, said, "Based on the results from our ORBIT I clinical study, demonstrating the safety in treating severely calcified coronary lesions our orbital platform technology may be well suited for the removal of calcified plaque in coronary arteries. Our pivotal 443-patient ORBIT II PMA clinical study has recently concluded and we are nearing completion of an FDA submission to secure a coronary indication for our technology."
CSI completed enrollment in the ORBIT II trial in November of 2012. ORBIT II is CSI's pivotal coronary IDE trial studying this problematic subset of patients. CSI is targeting the end of this quarter to submit its Premarket Approval (PMA) package to the FDA.
CSI Booth at CRT: Feb. 25 - 26
Visit CSI at booth #112, 8 a.m. - 5 p.m. today and 9 a.m. - 2 p.m. Tuesday, Feb. 26, to meet the company's calcium experts and learn more about CSI's unique orbital technology.
About Coronary Artery Disease
Coronary Artery Disease (CAD) is a life-threatening condition and leading cause of death in men and women in the United States. CAD occurs when a fatty material called plaque builds up on the walls of arteries that supply blood to the heart. The plaque buildup causes the arteries to harden and narrow (atherosclerosis), reducing blood flow. The risk of CAD increases if a person has one or several of the following: high blood pressure, abnormal cholesterol levels, diabetes, or family history of early heart disease. CAD affects an estimated 16.8 million people in the United States and is the most common form of heart disease. Heart disease claims more than 600,000 lives, or 1 in 4 Americans, in the United States each year.
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, over 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.
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 (News - Alert), death, dissection, perforation, distal embolization, thrombus formation, hematuria, abrupt or acute vessel closure, or arterial spasm.