The FDA today granted PMA approval to the Diamondback 360 Coronary Orbital Atherectomy System (OAS) for the treatment of severely calcified coronary arteries. Cardiovascular Systems, the manufacturer of the device, said that the OAS was the first new coronary atherectomy system to receive FDA approval in 2 decades. The company said it would begin a controlled launch of the device immediately, focusing initially on "a limited number of the top medical institutions in the United States."
The FDA approval was based on results of the ORBIT II study, a prospective, single-arm, multi-center study which evaluated the safety and efficacy of the OAS system in patients with severely calcified coronary lesions. The company said that it was "the first study in history that sought approval for treating these lesions." At 30 days, 89.8% of patients in the study were free of major adverse cardiac events, the primary outcome of the study.
Atherectomy, as cardiologists who have been around for a while will remember, has had a very long and torturous history in interventional cardiology. Although interventional cardiologists have been known for their ready adoption of new technology, it is unclear at this point how willing they will be to utilize a new atherectomy device.
Medtronic Launches Aspiration Catheter
In separate news, Medtronic yesterday announced the launch of its Export Advance aspiration catheter for coronary thrombus removal. The device was recently approved by the FDA. The company said the device features a pre-loaded stylet that "increases the deliverability and kink resistance of the new device while traversing the vasculature to reach the aspiration site."
