The Food and Drug Administration (FDA) has granted 510(k) clearance to the Ascendx VCF Repair System, produced by Ascendx Spine, Inc., of Winter Park, Florida. Previously cleared by the FDA is the company’s Acu-Cut Vertebral Augmentation System. Both products are used to treat vertebral compression fractures (VCF) and both have been approved for marketing in Europe.
A vertebral compression fracture forces a vertebra to collapse. When that happens, the spinal column above the fracture assumes an abnormal forward curve, resulting in back pain and a hunchbacked appearance. Current standard procedures for treating VCFs are vertebroplasty and kyphoplasty. Ascendx officials say that while traditional technologies require passing next to both sides of the spinal cord to reach the entire vertebral body, the Ascendx products are designed to achieve this through minimally invasive single-sided access.
“We are extremely pleased that both of our products, the Ascendx VCF Repair System and the Ascendx Acu-Cut Vertebral Augmentation System, are now FDA-cleared and CE-marked, ” said Julian M. Mackenzie, CEO of Ascendx Spine. “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.”
Ascendx Spine Inc. is a medical device company focused on the development and commercialization of innovative orthopedic devices for the spine and trauma markets.
