Titan Spine, LLC announced today that it began limited market release of its ENDOSKELETON® TT system, a new transforaminal lumbar interbody fusion (TLIF) device. The ENDOSKELETON® TT received 510(k) clearance from the U.S. Food and Drug Administration April 15, 2009. This represents the second clearance and product for Titan Spine as the company builds its portfolio of bioactive spinal devices.
The ENDOSKELETON® TT is indicated for use in adults with Degenerative Disc Disease in the lumbar spine. Dr. Gerard Girasole, Orthopedic Surgeon at the Orthopaedic & Sports Medicine Center in Connecticut, performed the first surgery. “I felt the cage gave great structural support. The device provides immediate binding to the endplates. Once implanted, due to the open design, you are able to pack large amounts of bone graft not only through the cage, but also to fully pack the interbody space.” The large windows used for graft packing also allow radiographic visualization and assessment of the fusion mass.
Jennifer Schneider, Project Leader for the new system, said, “The ENDOSKELETON® TT is a continuation of the design principles that made the ENDOSKELETON® TA successful; a biomechanically relevant design, proven surface technology, and intuitive instrumentation that facilitates an easy surgical technique.” The unique surface technology utilized in both product lines provides a press-fit for initial stability, and also promotes bone in growth.
Steve Cichy, Vice President of Sales and Marketing for Titan Spine, states, “As with the ENDOSKELETON® ALIF device, the ability to have greater surface area contact clearly resonates with the surgeon when discussing contact to the endplates. Furthermore, the opportunity to utilize the TLIF device as a stabilizer of the motion segment as opposed to a spacer allows the surgeon to have the interbody device take part in the fusion process.”
The ENDOSKELETON® TT was released approximately 4 weeks ago to select surgical sites; however, over 20 successful cases have already been performed to date. Kevin Gemas, President of Titan Spine, stated, “The initial commercial launch of the Endo TT exceeded our expectations across the board with respect to surgeon acceptance and early post-op patient outcomes. We are more confident than ever that the Endo TT will be a significant contributor to the Titan family of bioactive interbody devices for years to come.” Titan Spine is currently expanding its inventory to meet the increased demand for its products and is also on schedule to release 3 new bioactive spinal implants by the end of Q2 2010.
Source: Titan Spine