WINTER PARK, Fla.–(EON: Enhanced Online News)–AOI Medical, Inc. (now Ascendx Spine™ www.ascendxspine.com) has receivedISO 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).
“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”
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.
About Ascendx Spine™
Based in Winter Park, Florida, Ascendx Spine™ is a medical device company focused on the development and commercialization of innovative orthopedic devices for the spine and trauma markets. Its initial focus is the Ascendx VCF Repair System for the treatment of a vertebral compression fracture (VCF). A VCF 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.
Warning: 510(k) for Ascendx VCF Repair System is pending. Neither product—Ascendx VCF Repair System or Ascendx VCF Augmentation System—is available for sale in the United States.
Contacts
Ronald Trahan Associates Inc.
Ronald Trahan, APR, +1 508 359 4005, ext. 108
