Titan Spine has received clearance from the U.S. Food and Drug Administration to commercially release its Endoskeleton TL system.
The spinal fusion system utilizes a lateral approach and is the first lateral fusion device to feature surface technology that is designed to participate in the fusion process. The device incorporates Titan's proprietary roughened titanium surface technology, which is designed to create an enhanced environment for bone growth at the cellular level.
"The Endoskeleton TL device is the first application of surface technology to the lateral approach," said Paul Slosar, MD, CMO of Titan Spine. "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."
Kade Huntsman, MD, an orthopedic spine surgeon with the Salt Lake Orthopaedic Clinic in Salt Lake City, performed the first surgeries using the device on July 9.
Established in 2006, Titan Spine focuses on the design, manufacture and marketing of titanium interbody cage devices that participate in the fusion process. The company markets its products worldwide and recently received approval for its Endoskeleton interbody fusion device in New Zealand and Australia. It also expanded its Endoskeleton line of interbody devices to the United Kingdom and Spain.
The Endoskeleton TL system is part of a fast-growing implantable medical devices market that is expected to reach $73.9 billion by 2018, according to a Transparency Market Research report. Titan Spine faces competition from numerous device manufacturers including ChoiceSpine and Expanding Orthopedics, both of which recently released or received FDA clearance for spinal devices in the last month or so.
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