ORBIT II Data for CSI's Diamondback 360 Coronary System Presented at EuroPCR

June 2, 2014—Cardiovascular Systems, Inc. (CSI) announced new 1-year data and an economic analysis from its ORBIT II coronary study in a late-breaking presentation at the EuroPCR 2014 conference, which took place May 20–23, in Paris, France. The data demonstrated a freedom from major adverse cardiac events rate of 84% and a freedom from target lesion revascularization rate of 95%. Jeffrey Chambers, MD, of Metropolitan Heart and Vascular Institute in Minneapolis, Minnesota, presented the data.

CSI advised that Dr. Chambers also highlighted key economic statistics revealing that patients treated with CSI’s Diamondback 360 coronary orbital atherectomy system (OAS) have been associated with shorter lengths of hospital stay and lower readmission rates than those treated with other atherectomy devices or stenting alone, suggesting an estimated cost savings of more than $4,000 per patient for the treating institutions. The economic statistics are derived from a medical resource utilization analysis for both the index procedure and related readmission within 30 days of discharge from the ORBIT II clinical trial compared to Medicare data available at that time (MedPAR data with code 414.4 between October 1, 2011, and September 30, 2012).

ORBIT II is CSI’s pivotal study that evaluated the safety and effectiveness of the company’s orbital atherectomy technology in coronary arteries. CSI completed ORBIT II’s enrollment of 443 patients at 49 medical centers in the United States in November 2012. On October 21, 2013, the company received approval from the US Food and Drug Administration to market the Diamondback 360 coronary OAS as a treatment for severely calcified coronary arteries.

Also at EuroPCR, new ORBIT II data were presented by Dr. Chambers, Stevan I. Himmelstein, MD, of the Stern Cardiovascular Center in Memphis, Tennessee, and Arthur Lee, MD, of the Cardiac and Vascular Institute in Gainesville, Florida. 

According to CSI, the results detail 30-day outcomes in patients with impaired renal function who were treated with the Diamondback 360 coronary OAS to prepare severely calcified coronary lesions prior to stent deployment. A key finding was that, despite being an older demographic with longer lengths of calcium, patients with impaired renal function who were pretreated with the OAS had similar rates of procedural success (successful stent delivery and < 50% residual stenosis) compared with patients without impaired renal function.