Cardiovascular Systems Gets IDE for ORBIT II Study

Cardiovascular Systems has received a conditional investigational device exemption (IDE) for a clinical trial for its Diamondback 360 system to treat calcified coronary lesions, the company says. The pivotal ORBIT II trial will enroll as many as 100 patients and evaluate the safety and effectiveness of the device. “The U.S. market for coronary interventions is currently estimated at more than $4 billion, representing 1.3 million procedures each year,” David Martin, company president and CEO, says.