FDA clears Endoskeleton TAS anterior fusion device for the lumbar spine

184

The US Food and Drug Administration has cleared the Endoskeleton TAS system (Titan Spine) for lumbar spine fusion.

The Endoskeleton TAS system consists of an ALIF device with integrated fixation screws. The regulatory clearance is the fifth 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.


Robert Henderson, orthopaedic surgeon at Dallas Spine Care in Dallas, Texas, USA, performed one of the first implantations of the Endoskeleton TAS, he commented, “I felt the procedure went very well and the surgical technique was simple and straightforward.”


“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 stabilisation can be avoided,” Henderson added.


Fred Geisler, neurosurgeon at The Chicago Back Institute in Chicago, Illinois, USA, was also one of the first surgeons to implant the device, he said, “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.”  


“The combination of immediate stabilisation 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 US$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.”