The FDA has cleared Cardiovascular Systems to conduct the ORBIT II clinical trial to evaluate the safety and efficacy of its peripheral plaque-disolving catheter, the Diamondback 360, in the coronary arteries.
The FDA’s conditional Investigational Device Exemption approval will permit the company to examine 100 patients at 50 U.S. sites using its Diamondback 360 percutaneous orbital atherectomy system. The device, equipped with a diamond-coated crown for the removal of calcific and fibrocalcific plaque, was approved by the FDA in 2007 for use in peripheral arteries.
Approval for the trial is based on the results of the 2008 ORBIT I coronary trial that enrolled 50 patients. According to the St. Paul, Minn.-based company, the device proved successful in 98 percent of patients and had 94 percent success during acute procedures.
The ORBIT II clinical trial will begin in early 2010 and will be led by Jeffrey Chambers, MD, interventional cardiologist with Metropolitan Cardiovascular Consultants in Minneapolis.