WINTER PARK, Fla.--(BUSINESS WIRE)--Ascendx Spine™ (www.ascendxspine.com) announced today that it has received FDA clearance to market in the United States its Acu-Cut Vertebral Augmentation System for treatment of 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 Acu-Cut Vertebral Augmentation System is designed to be an alternate solution for physicians who are currently treating VCF patients. Acu-Cut is a uni-pedicular vertebral augmentation system that creates a cavity for precise cement placement.
While traditional technologies require passing next to both sides of the spinal cord to reach the entire vertebral body, the Acu-Cut Vertebral Augmentation System is designed to achieve this through single-sided access.
“We are very excited to receive the FDA’s clearance of our first product to market in the U.S.,” said Julian M. Mackenzie, CEO of Ascendx Spine.
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.