Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), has received Food and Drug Administration unconditional Investigational Device Exemption (IDE) approval, allowing the company to proceed with ORBIT II, a pivotal trial to evaluate the safety and effectiveness of CSI's Diamondback 360® System in the coronary arteries. CSI received conditional IDE approval for the ORBIT II study in January 2010. The pivotal trial will initially enroll up to 100 patients at as many as 50 U.S. sites, with the potential to enroll up to 429 patients. Dr. Jeffrey Chambers, an interventional cardiologist with Metropolitan Cardiovascular Consultants, Minneapolis, is the principal investigator.
“We are optimistic the ORBIT II study will reinforce the safety and effectiveness of removing plaque using the Diamondback 360° System, as already shown in our ORBIT I coronary feasibility study of 50 subjects and in the treatment of more than 25,000 patients to-date with peripheral arterial disease (PAD).”
The Diamondback 360° is designed to be well suited for removing calcific and fibrocalcific plaque in coronary lesions. The system uses a diamond-coated crown with a unique orbital mechanism of action to sand and remove hardened plaque, which may facilitate more effective stent placement and restoration of blood flow in the coronary arteries. The orbital action also allows continuous saline and blood flow through the lesion, which may be advantageous during treatment.
"The unconditional FDA IDE approval continues CSI's progress toward regulatory approval for a coronary application and potential significant market expansion for our product technology," said David L. Martin, president and CEO of Cardiovascular Systems. "We are optimistic the ORBIT II study will reinforce the safety and effectiveness of removing plaque using the Diamondback 360° System, as already shown in our ORBIT I coronary feasibility study of 50 subjects and in the treatment of more than 25,000 patients to-date with peripheral arterial disease (PAD)."
In 2008, CSI completed the ORBIT I coronary trial, the first in-human feasibility study, which enrolled 50 patients in India. The Diamondback 360° was shown to be successful in 98 percent of patients with calcified lesions, and the acute procedural success rate, including stent placement, was 94 percent. These results met the company's safety and efficacy endpoints and were among the data the FDA considered in granting the ORBIT II IDE approval.
Dr. Chambers said, "Coronary arterial disease is the most common form of heart disease in the United States, affecting more than 16 million people. After the successes of the ORBIT I study, we are eager to expand the number of coronary patients treated with the Diamondback 360°, and acquire acute and long-term data. We believe the unique features of the Diamondback 360° are designed specifically to remove calcified plaque in coronary arteries to facilitate stent placement."
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