FDA has granted Cardiovascular Systems (CSI) an unconditional investigational device exemption (IDE) approval, allowing the company to proceed with Orbit II, a pivotal trial to evaluate the safety and effectiveness of its Diamondback 360 System in the coronary arteries.
According to CSI, the pivotal trial is expected to initially enroll up to 100 patients at as many as 50 US 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.
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 Orbital mechanism of action to sand and remove hardened plaque, which may facilitate 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.
Reportedly, 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% of patients with calcified lesions, and the acute procedural success rate, including stent placement, was 94%. The results met the company’s safety and efficacy endpoints and were among the data the FDA considered in granting the Orbit II IDE approval.
David Martin, president and CEO of Cardiovascular Systems, said: “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.
“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).”