Apr 5 2011
Titan Spine, a medical device surface technology company focused on the development of innovative spinal interbody fusion implants, announced today that it has received CE Mark Certification to commercially release its line of Endoskeleton® lumbar interbody fusion devices in Europe. The implants, which consist of the Endoskeleton® TA (ALIF), Endoskeleton® TT (TLIF), and Endoskeleton® TO (PLIF and Oblique), feature a unique roughened titanium surface topography that is designed to promote rapid bony integration and subsequent fusion. The company plans to immediately begin conducting surgical cases within the European Union.
“The flexibility in allowing for a dynamic exchange of ideas to ensure that all domestic regulatory requirements are maintained while including additional requirements for the European Union was vital to the success of this project.”
"Obtaining the CE Mark on our lumbar systems is a significant milestone for our company," commented Kevin Gemas, President of Titan Spine. "This will allow us to aggressively market our titanium surface technology in Europe, where the $160 Million-dollar interbody marketplace is trending towards titanium at a rate that even exceeds that of the United States. In addition, we plan to obtain CE Mark Certification on our cervical product line in the near future to further increase our addressable market in Europe."
Scott Van Ells, Senior Quality Assurance & Regulatory Affairs Director for Titan Spine, spearheaded the project. "The timeframe in which we were able to accomplish the CE Mark accreditation speaks volumes to our Quality Management System and the efforts of the entire organization," he stated. "The flexibility in allowing for a dynamic exchange of ideas to ensure that all domestic regulatory requirements are maintained while including additional requirements for the European Union was vital to the success of this project."
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