FDA clears Ascendx Acu-Cut Vertebral Augmentation System

The US Food and Drug Administration (FDA) has approved Ascendx Spine's Acu-Cut Vertebral Augmentation System to treat vertebral compression fractures (VCF).

Acu-Cut is a uni-pedicular vertebral augmentation system which is designed to create a cavity for precise cement placement.

To reach the entire vertebral body, the traditional technologies required to pass next to both sides of the spinal cord, while the Acu-Cut Vertebral Augmentation System is designed to achieve this through single-sided access.

Ascendx Spine said Julian Mackenzie CEO they are very excited to receive the FDA’s clearance of their first product to market in the US.