•One-year Data from Trial Shows Strong Rates of Freedom from Target Revascularization, Cardiac Death and Major Adverse Cardiac Events (MACE)
•New Economic Analysis Demonstrates Treatment with CSI’s Coronary Orbital Atherectomy System Provides Measurable Cost Savings

ST. PAUL, Minn.--(BUSINESS WIRE)-- Cardiovascular Systems, Inc. (CSI), presented one-year data and a new economic analysis from its ORBIT II coronary study in a late-breaker session at the Society for Cardiovascular Angiography and Interventions (SCAI) 2014 conference, which took place in Las Vegas, May 28-31. The ORBIT II study of the company’s Diamondback 360® Coronary Orbital Atherectomy System (OAS) evaluated the safety and effectiveness of CSI’s technology in treating severely calcified lesions in coronary arteries.

Dr. Jeffrey Chambers of the Metropolitan Heart and Vascular Institute, Minneapolis, presented one-year data that demonstrates freedom from target lesion revascularization and target vessel revascularization of 95 percent and 98 percent, respectively. The ORBIT II study also reported freedom from cardiac death of 97 percent.

Additionally, a key economic analysis by economist Dr. Louis Garrison, Jr., University of Washington, Seattle, was presented. Data showed that patients treated with the Diamondback 360 Coronary OAS in the ORBIT II study have been associated with shorter hospital stays and lower retreatment rates, compared to Medicare patients treated with traditional technologies, resulting in an average lower cost of $3,200 per patient.

The Medicare comparison sample was drawn from the 100 percent Standard Analytical File for the period September 2011 through December 2012. This data, presented for the first time at SCAI 2014, builds on a previous ORBIT II economic analysis by including a larger investigation of ORBIT II subjects and both outpatient and inpatient data, versus in-patient analysis only.

“This ORBIT II data demonstrates that the orbital atherectomy system from CSI provides one-year durable results, while giving physicians a cost effective way to address coronary calcium in these difficult-to-treat patients,” said Dr. Chambers.

David L. Martin, CSI president and chief executive officer, said: “ORBIT II results clearly show that by reducing severely calcified plaque with our technology, physicians not only reduce MACE and cardiac death rates, they also improve freedom from target vessel revascularization in this difficult-to-treat patient population, which lowers costs. This is important information for physicians, so we’re pleased that SCAI selected our data for a late breaking presentation.”

CSI completed ORBIT II enrollment of 443 patients at 49 U.S. medical centers in November 2012. On October 21, 2013, the company received PMA approval from the U.S. Food and Drug Administration (FDA) to market its Diamondback 360 Coronary Orbital Atherectomy System as a treatment for severely calcified coronary arteries.

Source: Cardiovascular Systems, Inc.