AOI Medical, Inc. (now Ascendx Spine™ www.ascendxspine.com) has received ISO 13485 Certification and CE marking approval for its Ascendx VCF Repair System and its Ascendx Acu-Cut Vertebral Augmentation System to treat vertebral compression fractures (VCF).
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.'
"The Ascendx VCF Repair System and the Ascendx Acu-Cut Augmentation System are designed for the treatment of spinal fractures by spine surgeons and interventional radiologists," said Julian M. Mackenzie, CEO of Ascendx Spine™.
Mr. Mackenzie added that the Company also has a 510(k) submission pending FDA clearance for its Ascendx VCF Repair System in 2011. A 60-patient, multicenter U.S. clinical trial has been successfully completed.