Clinical and Economic Data Presented From CSI's ORBIT II Coronary Study

June 4, 2014—Cardiovascular Systems, Inc. (CSI) announced that 1-year data and a new economic analysis from its ORBIT II coronary study were presented at the Society for Cardiovascular Angiography and Interventions SCAI 2014 conference, which took place May 28–31 in Las Vegas, Nevada. The ORBIT II study of CSI’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.

According to CSI, the 1-year data demonstrated freedom from target lesion revascularization and target vessel revascularization of 95% and 98%, respectively. The ORBIT II study also reported freedom from cardiac death of 97%. Jeffrey Chambers, MD, of the Metropolitan Heart and Vascular Institute in Minneapolis, Minnesota, presented the 1-year data during a late-breaking trial session at the SCAI 2014 meeting.

Additionally, a key economic analysis 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% Standard Analytical File for the period September 2011 through December 2012. These data, presented for the first time at SCAI 2014, build 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. The data were presented by economist Louis Garrison, Jr., PhD, from the Pharmaceutical Outcomes Research & Policy Program at the
University of Washington School of Pharmacy in Seattle, Washington.

In the company’s press release, Dr. Chambers commented, “This ORBIT II data demonstrates that the orbital atherectomy system from CSI provides 1-year durable results, while giving physicians a cost-effective way to address coronary calcium in these difficult-to-treat patients.”

CSI advised that ORBIT II enrollment of 443 patients at 49 medical centers in the United States was complete in November 2012. In October 2013, the company received premarket approval from the US Food and Drug Administration (FDA) to market its Diamondback 360 coronary orbital atherectomy system as a treatment for severely calcified coronary arteries. CSI announced the market launch of the device in December 2013.