Cardiovascular Systems’ Orbital Atherectomy Technology Highlighted at ACC Innovations Forum

ST. PAUL, Minn., & SAN FRANCISCO–(BUSINESS WIRE)– Cardiovascular Systems, Inc. (CSI) (NAS: CSII) , was featured as part of the “Innovation and Technology Adoption” presentation during the Innovations Educational Forum at the 2013 American College of Cardiology (ACC) conference in San Francisco. Dr. Glen Nelson, CSI‘s Chairman of the Board, moderated the session.

Data presented by Dr. William Gray, Director of Endovascular Services, Columbia University, New York, N.Y., illustrated that calcified lesions are underestimated, challenging to treat and lead to increased complications. The presentation demonstrated the effectiveness of CSI‘s peripheral orbital atherectomy system (OAS) in treating calcified lesions and its ability to change vessel compliance—minimizing vascular injury that may lead to restenosis.

Additionally, follow-up on prior CSI studies shared during the forum showed that CSI‘s OAS has consistent procedural outcomes, low complications and long-term durability in treating calcified lesions.

Click here to see the full abstract.

Also presented at ACC were pivotal trial results from CSI‘s ORBIT II study of patients with severely calcified coronary arteries. ORBIT II is evaluating the safety and effectiveness of the company’s OAS in treating one of the most challenging patient populations. At 30 days, patient outcomes exceeded the study’s primary safety and efficacy endpoint targets by a significant margin. Moderate to severe arterial calcium is present in nearly 40 percent of patients undergoing a percutaneous coronary intervention, according to estimates.

Additionally, moderate to severe calcium contributes to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used, including a significantly higher occurrence of death and major adverse coronary events (MACE). A coronary approval would open up a large, underserved market opportunity for CSI, estimated to exceed $1.5 billion annually in the United States.

CSI completed ORBIT II enrollment of 443 patients at 49 U.S. medical centers in November 2012. CSI is targeting the end of March 2013 to submit its Premarket Approval application to the Food and Drug Administration.

Click here to see CSI‘s ORBIT II Pivotal Trial results.

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 …read more
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