Atherectomy System to be Tested in the Coronary Arteries
January 15, 2010 – The FDA has approved a trial to evaluate the safety and effectiveness of the Diamondback 360º atherectomy system in treating calcified coronary lesions.
Cardiovascular Systems Inc. (CSI) this week received FDA conditional investigational device exemption (IDE) approval for the device indication, allowing the pivotal trial, ORBIT II, to begin in early 2010. The trial will initially enroll up to 100 patients at as many as 50 U.S. sites. Jeffrey Chambers, M.D., an interventional cardiologist with Metropolitan Cardiovascular Consultants, Minneapolis, is the principal investigator for ORBIT II.
The Diamondback 360º was FDA cleared in 2007 for the treatment of peripheral arterial disease. The company seeks to expand its indications to include the coronary arteries. The manufacturer said it could be a complementary tool to stents and angioplasty, and play a significant role in removing calcified or fibrocalcific disease to increase the effectiveness of the other therapies.
In 2008, CSI completed the first in-human ORBIT I coronary trial, a feasibility study which enrolled 50 patients in India. The Diamondback 360° was shown successful in 98 percent of patients, and the acute procedural success rate was 94 percent. 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,” said Dr. Chambers. “In the feasibility study, acute procedural outcomes were positive, and we believe the use of the device also may 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.”
The Diamondback 360° catheter has a diamond-coated crown and unique orbital mechanism of action, ideally suited for removing calcific and fibrocalcific plaque. The coronary platform has been designed for ease-of-use, short procedure times and a minimized risk of complications by using a low-profile catheter, a turbine-powered controller and the proprietary ViperWire Guide Wire.
For more information: www.csi360.com