The mark clears AxioMed for the introduction of Freedom, an elastomeric total spinal disc replacement device, into the European Union market. AxioMed describes the product as a “viscoelastic one-piece, next generation total disc replacement featuring a polymer core, designed with the goal of restoring function of the spine and reducing pain and disability.”
AxioMed previously received a CE mark for its Freedom lumbar disc in 2009.
“With the Freedom lumbar and cervical discs now both CE marked, we will be able to provide a complete next generation elastomeric disc product line for patients and surgeons in the European Union,” said Patrick McBrayer, AxioMed’s president and CEO, in the release. “Our European Union lumbar clinical data, published in peer reviewed spine journals, demonstrate that Freedom technology has been shown to provide patients pain relief, reduced disability and improved lifestyle, based on monitored outcomes and feedback. We are also active in our multi-center pivotal clinical study under an Investigational Device Exemption for our Freedom lumbar disc with both efficacy and economic endpoints. Our goal is to have the most advanced and complete total disc product line in the United States and European Union.”
AxioMed is headquartered in Garfield Heights, Ohio.
Related Articles on Product Approvals:
U-Systems Receives FDA Premarket Approval Letter for somo*v Automated Breast Ultrasound System
St. Jude Medical Receives FDA Approval for Assura Implantable Defibrillators
Interrad Receives FDA Clearance for Four Additional Sizes of SecurAcath Device
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
