News | Atherectomy Devices | May 06, 2016

Final Three-Year ORBIT II Atherectomy Study Results Shared

Diamondback 360 Coronary Orbital Atherectomy System demonstrates 7.8 percent three-year target lesion revascularization rate

CSI, Cardiovascular Systems Inc, Diamondback 360 Coronary Orbital Atherectomy System, OAS, ORBIT II study, three-year results, SCAI 2016
ORBIT II study, three-year results, chart, SCAI 2016

ORBIT II study three-year results presented at SCAI 2016

May 6, 2016 — Cardiovascular Systems Inc. shared three-year results from its pivotal ORBIT II study in a featured clinical research presentation at the 2016 Society for Cardiovascular Angiography and Interventions (SCAI) conference in Orlando, Fla.

The ORBIT II study evaluated the safety and efficacy of the company’s Diamondback 360 Coronary Orbital Atherectomy System (OAS) Classic Crown in treating patients with de novo severely calcified coronary lesions.

Jeffrey Chambers, M.D., of Metropolitan Heart and Vascular Institute, Mercy Hospital, Minneapolis, presented the final three-year results. Chambers said, “Using the coronary OAS to treat calcium prior to stent implantation delivers procedural success and durable long-term outcomes in these complex patients with severely calcified coronary lesions.”

Recent publications have indicated that women are an under-studied population in percutaneous coronary intervention (PCI) clinical studies. At SCAI, Chambers presented the results of an ORBIT II gender sub-analysis in addition to the main three-year results. He concluded, “In the ORBIT II trial, similar rates of MACE through three years post-procedure exist in both males and females. This is significant, and an example of CSI’s thoroughness when conducting clinical studies.”

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