FDAnews
www.fdanews.com/articles/200951-cardiovascular-systems-gains-ce-mark-for-atherectomy-device
CE mark

Cardiovascular Systems Gains CE Mark for Atherectomy Device

January 20, 2021

Cardiovascular Systems has been granted CE mark certification for its Diamondback 360 coronary orbital atherectomy system.

The device is used to treat calcified and fibrotic plaque in blood vessels throughout the leg and heart, and it includes technology that enables tracking, easier removal and smoother repositioning of the device. The company also received European clearance for the accompanying ViperWire Advance with Flex Tip coronary guidewire.

The Diamondback 360 can treat all blood vessel calcium atheroscleroses, the company said, including nodular, irregular and ring-shaped.

View today's stories