Ascendx Spine™, Inc., has received FDA 510(k) clearance for its Ascendx VCF Repair System. This follows earlier clearance for the company’s Acu-Cut device, meaning the company can now offer a complete system for Vertebral Compression Fracture (VCF) repair.
Florida based device company Ascendx Spine™, Inc., focuses on the development and commercialisation of innovative orthopedic devices for the spine and trauma markets.
A vertebral compression fracture forces a vertebra to collapse, and the spinal column above it to assume an abnormal forward curve, resulting in considerable back pain and a hunchbacked appearance. Current standard procedures for treating VCFs are ‘vertebroplasty’ and ‘kyphoplasty.’
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. The Ascendx VCF Repair System is designed to enable the physicians, including spine surgeons and interventional radiologists, to place a single bolus of bone cement (PMMA) in the center of the vertebra with the balloon still inflated.
Ascendx Spine has already received FDA clearance for its Ascendx Acu-Cut Vertebral Augmentation System prior to this new approval. Both products are also approved for marketing in Europe.
“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 commercialisation of both products in the United States and Europe via a hybrid strategy of select spine distributors and a direct sales force.”
Source: Ascendx Spine, Inc.