The US Food and Drug Administration (FDA) has granted 510(k) clearance to Ascendx Spine's minimally invasive Ascendx VCF Repair system, designed for the treatment of vertebral compression fractures (VCFs).
The VCF Repair system, unlike the standard vertebroplasty and kyphoplasty procedures which requires both sides for the access, reaches the entire vertebral body by passing through single side of the spinal cord.
In addition, the system places a single bolus of bone cement (PMMA) in the center of the vertebra with the balloon still inflated.
Ascendx Spine CEO Julian Mackenzie said the Ascendx VCF Repair system, along with its Ascendx Acu-Cut Vertebral Augmentation system, are now FDA-cleared and CE-marked.
"We look forward to commencing the commercialization of both products in the United States and Europe via a hybrid strategy of select spine distributors and a direct sales force," Mackenzie added.