Titan Spine Receives FDA Clearance to Launch Endoskeleton ® TAS ALIF Interbody Fusion Device with Integrated Fixation

Titan Spine, a medical device surface technology company focused on the development of innovative spinal interbody fusion implants, announced today that it has received FDA clearance to commercially release its Endoskeleton® TAS system, consisting of an ALIF device with integrated fixation screws. The regulatory clearance is the fifth such approval for the company and supplements its current line of TLIF, PLIF, ALIF, and cervical interbody implants.

The Endoskeleton® TAS incorporates the same macro, micro, and nano surface textures as the company’s Endo TA ALIF device, which has been shown to elicit a superior osteogenic response in comparison to other commercially available interbody materials. In addition, the TAS features three integrated grit-blasted screws that allow up to ten degrees of medial/lateral or anterior/posterior angulation.

One of the first implantations of the Endoskeleton® TAS was conducted by Dr. Robert Henderson, Orthopedic Surgeon with Dallas Spine Care in Dallas, Texas. “I felt the procedure went very well and the surgical technique was simple and straightforward,” commented Dr. Henderson. “I am pleased Titan has added the supplemental fixation feature to its ALIF device that I have been using with great success to date. It is a nice option to have for specific spinal pathologies where supplemental posterior stabilization can be avoided.” Dr. Fred Geisler, Neurosurgeon with The Chicago Back Institute in Chicago, Illinois, was also one of the first surgeons to implant the device. “I was particularly impressed with the purchase of the screws and how the roughened surface of the implant prevented the device from moving during screw insertion,” said Dr. Geisler. “The combination of immediate stabilization and the osteoinductive properties of the implant’s micro and nano textures represent a significant advance in spine surgery. I look forward to adding the TAS to my practice.”

Kevin Gemas, President of Titan Spine, commented, “The addition of the Endoskeleton® TAS to our product line now allows us to address approximately 90% of the interbody market that is approaching $1 billion in domestic annual sales. We feel that we are well positioned to continue to increase our market share and meet the growing need of spine surgeons looking for innovative interbody implants that create a superior osteogenic environment for their patients.”

About the Company – Titan Spine, LLC is a privately-owned medical implant surface technology company in Mequon, Wisconsin that is focused on the design and manufacturing of proprietary interbody fusion devices for the spine. Founded in 2006, the company is committed to advancing the science of surface engineering to enhance the treatment of various pathologies of the spine that require fusion.

Interestingly the company does not state whether it has CE mark approval for the device, although we note they are exhibiting at Eurospine in Milan this week.

Source: TitanSpine