FDA Approves Study of CSI's Diamondback 360° in CAD

January 14, 2010—Cardiovascular Systems, Inc. (CSI, St. Paul, MN) has received conditional investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to evaluate the safety and effectiveness of the company's Diamondback 360° orbital atherectomy catheter system for treating calcified coronary lesions. With this conditional approval, CSI is authorized to begin its pivotal trial, ORBIT II, in early 2010. ORBIT II will initially enroll up to 100 patients at as many as 50 sites in the United States. Jeffrey Chambers, MD, is the principal investigator for ORBIT II.

The Diamondback 360° received FDA 510(k) marketing clearance in 2007 for treating peripheral artery disease. The catheter has a diamond-coated crown and orbital mechanism of action. It features a low-profile catheter, a turbine-powered controller, and the company's ViperWire guidewire.

In 2008, CSI completed the first-in-human ORBIT I coronary trial, a feasibility study that enrolled 50 patients in India. The Diamondback 360° was shown to be successful in 98% of patients, and the acute procedural success rate was 94%. These results met the company's safety and efficacy endpoints and were among the data the FDA considered in granting conditional IDE approval.

“We have seen the advantages of using the Diamondback 360° in removing calcified coronary plaque prior to using stents or angioplasty,” commented Dr. Chambers. “In the feasibility study, acute procedural outcomes were positive, and we believe the use of the device may also contribute to improved long-term outcomes in patients with difficult-to-treat disease. We look forward to expanding our understanding of this platform technology for a coronary indication.”