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.”
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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.”
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