FDA approves launch of Titan’s Endoskeleton TL device for lateral spinal fusion

14 July 2014 (Last Updated July 14th, 2014 18:30)

The US Food and Drug Administration (FDA) has granted approval to Titan Spine to commercially launch its Endoskeleton TL system, a spinal fusion solution that uses a lateral approach.

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The US Food and Drug Administration (FDA) has granted approval to Titan Spine to commercially launch its Endoskeleton TL system, a spinal fusion solution that uses a lateral approach.

Endoskeleton TL is the first device to feature surface technology that is designed to participate in the fusion process by creating an osteogenic response to the implant's topography.

The new device uses the company's roughened titanium surface technology to the lateral approach.

The titanium surface technology has been shown to upregulate the production of osteogenic and angiogenic factors that are critical for bone growth and fusion.

The device features large windows and large internal volumes to allow for bone graft packing, clear CT and MRI imaging, desired bone graft loading, and the ability to pack additional bone graft material within the device following implantation.

In July 2014, Salt Lake Orthopaedic Clinic orthopedic spine surgeon Kade Huntsman has performed the first surgery using the Endoskeleton TL device at St. Mark's Hospital in Salt Lake City.

Huntsman said for the first time, he was able to insert additional bone graft material in to a lateral device post-implantation, and the radiopaque nature of the TL made it extremely easy to place the device in the desired location.

"I am excited to offer the TL, and the benefits of its surface technology and design features, to my patients requiring lateral interbody fusion," Huntsman said.

"The TL is the byproduct of a unique collaboration between academic biomaterial scientists, spine surgeons, and industry experts to create a truly differentiated lateral interbody device that is designed to benefit both patients and surgeons."

The full line of Endoskeleton devices features the company's implant surface technology, consisting of a unique combination of roughened topographies at the macro, micro, and cellular levels.

The company said that the combination of surface topographies is designed to create an optimal host-bone response and actively participate in the fusion process by promoting new bone growth, encouraging natural production of bone morphogenetic proteins (BMP's) and creating the potential for a faster and more robust fusion.

Titan Spine chief medical officer Paul Slosar said: "The ability to orchestrate cellular behavior and promote bone growth in response to an interbody device has not been in the lateral surgeon's armamentarium until now.

"The TL is the byproduct of a unique collaboration between academic biomaterial scientists, spine surgeons, and industry experts to create a truly differentiated lateral interbody device that is designed to benefit both patients and surgeons.

"With the addition of the TL device, Titan Spine now offers its surface technology and complete line of titanium devices for virtually all interbody fusion spine surgery procedures in the cervical and lumbar spine."


Image: Titan Spine's Endoskeleton TL system. Photo: courtesy of Business Wire/ Titan Spine, LLC.