Titan Spine granted FDA clearance for Endoskeleton TO system

Titan Spine, a developer of novel interbody fusion implants, announced today that it has received FDA clearance to commercially release its Endoskeleton® TO system, which consists of a line of interbody devices placed through a Posterior Lumbar Interbody Fusion (PLIF) approach. The company plans to commercially release the product beginning in December, 2010.

“The Endoskeleton® TO incorporates the same innovative design features of our commercially-available cervical, ALIF and TLIF devices - a unique roughened Titanium surface that participates in the fusion process”

Dr. Gerard Girasole, Orthopaedic Surgeon at the Orthopaedic & Sports Medicine Center in Trumbull, CT, is very pleased with the announcement. "The launch of the Endoskeleton® TO is a significant milestone in the evolution of the Titan Spine product pipeline," said Dr. Girasole. "The PLIF/Oblique design is a perfect complement to the company's previously-released TLIF system and offers a viable option to spine surgeons that prefer a posterior approach to interbody fusion. I fully expect to achieve the same type of clinical outcomes with the Endoskeleton® TO that I have been enjoying with Titan's other interbody constructs."

This is the fourth regulatory clearance for the company. "The Endoskeleton® TO incorporates the same innovative design features of our commercially-available cervical, ALIF and TLIF devices - a unique roughened Titanium surface that participates in the fusion process," commented Chad Patterson, Director of Product Development and Operations for Titan Spine. "We chose to use Titanium due to its affinity to integrate with bone and its track record of success in other orthopedic applications. We feel the design and composition of our implants help to promote earlier bony ingrowth and stability in comparison to other available materials, thus leading to improved outcomes for our patients."