Cardiovascular Systems, Inc. (CSI) (Nasdaq: CSII), announces the first patient enrollment in its ORBIT II Investigational Device Exemption (IDE) clinical trial to evaluate the safety and effectiveness of its Diamondback 360® System in treating coronary arteries. The patient was treated by Dr. P.K. Khanna, an interventional cardiologist with Eisenhower Medical Center in Palm Springs, Calif. Dr. Khanna also treated patients in the 2008 ORBIT I coronary study of 50 patients in India. ORBIT I showed that the Diamondback 360° was successful in 98 percent of patients with calcified lesions, with an acute procedural success rate of 94 percent.
“The ORBIT II trial is another scientific step in obtaining irrefutable proof to establish the Diamondback 360° as an advantageous treatment alternative in both coronary and peripheral arterial disease (PAD). Our device has been instrumental in providing more than 25,000 patients and their families a new option for treating PAD.”
"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," Dr. Khanna said. "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 CSI's progress toward U.S. regulatory approval for a coronary application and a significant market expansion. 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.
"Our commitment to clinical rigor continues to advance with the recent completion of patient enrollment for both the CALCIUM 360° and COMPLIANCE 360° post-market peripheral studies, and now with the initiation of the ORBIT II coronary study," said David L. Martin, president and CEO of Cardiovascular Systems. "The ORBIT II trial is another scientific step in obtaining irrefutable proof to establish the Diamondback 360° as an advantageous treatment alternative in both coronary and peripheral arterial disease (PAD). Our device has been instrumental in providing more than 25,000 patients and their families a new option for treating PAD."
"This is the start of a new era in the treatment of coronary artery disease," said Dr. Jeffrey Chambers, 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 Diamondback 360° is distinctively designed to remove calcific and fibro-calcific plaque in coronary lesions thereby 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.
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