Cardiovascular Systems (CSI) has started patient enrollment in Orbit II Investigational Device Exemption (IDE) clinical trial to evaluate the safety and effectiveness of Diamondback 360 System in treating coronary arteries.
The Diamondback 360° is 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 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.
The Orbit II study advances CSI’s progress toward US regulatory approval for a coronary application and a 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.
Dr Khanna, an interventional cardiologist at Eisenhower Medical Center, said: “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.
“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.”
David Martin, president and CEO of CSI, said: “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.
“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.”