News | May 27, 2010

Pivotal Study Evaluates Benefits of Coronary Atherectomy

May 27, 2010 – The first patient was recently enrolled in the ORBIT II investigational device exemption (IDE) clinical trial to evaluate the safety and effectiveness of its Diamondback 360 atherectomy system in treating calcified coronary arteries.

“Severely calcified coronary lesions have frequently been excluded from other clinical studies over the past decade because they are a clinical challenge for coronary interventions,” said P.K. Khanna, M.D., an interventional cardiologist with Eisenhower Medical Center in Palm Springs, Calif. “I believe that the Diamondback 360° is an essential advancement in treating patients with this type of disease. This easy-to-use tool should prove — through the ORBIT II trial — to be safe and effective in treating calcified lesions in order to facilitate stent placement.”

The ORBIT II study advances Cardiovascular Systems Inc. (CSI) progress toward U.S. regulatory approval for a coronary application. CSI received unconditional FDA IDE approval for the ORBIT II study in April 2010. The pivotal trial will initially enroll up to 100 patients, with the potential to enroll up to 429 patients.

“This is the start of a new era in the treatment of coronary artery disease,” said Jeffrey Chambers, M.D., an interventional cardiologist with Metropolitan Cardiovascular Consultants, Minneapolis, and the principal investigator for the ORBIT II study. “We believe that the Diamondback 360° system will broaden our ability to safely and effectively treat more challenging patients.”

The device is designed to remove calcific and fibro-calcific plaque in coronary lesions to facilitating effective stent placement and restoring flow. With a diamond-coated crown and unique orbital mechanism of action, the system removes hardened plaque while allowing continuous saline and blood flow through the lesion, which may be advantageous during treatment.

In August 2007, the U.S. Food and Drug Administration (FDA) granted 510(k) market clearance for the use of the Diamondback 360° as a therapy for PAD (peripheral arterial disease). Since then, more than 25,000 procedures have been performed using the system.

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