US Food and Drug Administration approval for next generation spinal interbody fusion implant

For the first time, the US Food and Drug Administration (FDA) has approved a nanotechnology-enabled interbody spinal fusion implant, according to a Nov. 12, 2014 news item on Azonano,

Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Endoskeleton® line of interbody fusion implants featuring its next-generation nanoLOCKTM surface technology.

This clearance marks Titan’s line of Endoskeleton® spinal implants as the first FDA-approved interbody fusion devices to feature nanotechnology.

A Nov. 22, 2014 news item on Today’s Medical Developments.com provides more detail about the implants,

Titan’s new nanoLOCK surface technology enhances the company’s line of Endoskeleton devices with an increased amount of nano-scaled textures to up-regulate a statistically significant greater amount of the osteogenic and angiogenic growth factors that are critical for bone growth and fusion when compared to PEEK and the company’s current surface.

Barbara Boyan, Ph.D., dean of the School of Engineering at Virginia Commonwealth University, and an investigator in various Titan Spine studies, said, “This new surface technology further enhances Titan’s current surface and is the result of extensive research in how to create a significantly greater amount of nano-scaled textures that we have shown to be important for the osteogenic response necessary for fusion. The nanoLOCK surface topography is far different than what is found on titanium-coated PEEK implants. In addition, the nanoLOCK surface is not created by applying a coating, but rather is formed by a reductive process of the titanium itself. This eliminates the potential for delamination, which is a concern for products with a PEEK-titanium interface. My team is proud to collaborate with Titan Spine to help develop such a differentiated technology that is truly designed to benefit both patients and surgeons.”

Titan’s nanoLOCK surface is a significant advancement of the company’s first-generation surface. The patented nanoLOCK manufacturing process creates additional textures at the critical nano level. However, there are no changes to the device indications for use, design, dimensions, or materials. Additionally, mechanical testing demonstrated that the strength of the company’s line of Endoskeletonimplants are unaffected by the new surface treatment.

Earlier this year Titan Spine announced the first surgery using one of its Endoskeleton implants. From a July 14, 2014 Titan Spine press release,

Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to commercially release its Endoskeleton® TL system, a spinal fusion system utilizing a lateral approach. The Endoskeleton® TL represents the first lateral fusion 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 Endoskeleton® TL device utilizes Titan’s proprietary roughened titanium surface technology which has been shown to upregulate the production of osteogenic and angiogenic factors that are critical for bone growth and fusion. In addition, the design of the TL device incorporates large windows and large internal volumes to allow for significant 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. Members of the TL design team include Kade Huntsman, M.D., Orthopedic Spine Surgeon with the Salt Lake Orthopaedic Clinic in Salt Lake City, Utah; Andy Kranenburg, M.D., Co-Medical Director of the Providence Medford Medical Center Spine Institute in Medford, OR; Axel Reinhardt, M.D., Head of the Department of Spinal Surgery at the Specialized Orthopaedic Hospital in Potsdam, Germany; and Paul Slosar, M.D., Chief Medical Officer for Titan Spine.

Dr. Huntsman performed the first surgeries utilizing the Endoskeleton® TL on July 9th, 2014 at St. Mark’s Hospital in Salt Lake City, Utah. …

“The Endoskeleton® TL device is the first application of surface technology to the lateral approach,” commented Dr. Slosar. “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.”

The full line of Endoskeleton® devices features Titan Spine’s proprietary implant surface technology, consisting of a unique combination of roughened topographies at the macro, micro, and cellular levels. [emphasis mine] This 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.

It would seem the implant used in the July 2014 surgery is not nanotechnology-enabled, which suggests nanoLOCK is a next-generation implant being marketed only a few months after the first generation was made available. Unfortunately, the Titan Spine website is still partially (‘surface technology’ tab) under construction so I was not able to find more details about the technology. In any event, that’s quite a development pace.

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