Carlsbad, Calif – January 21, 2015 – Spinal Elements, a spine technology company, today announced that they recently received clearance through the United States Food and Drug Administration for a full line of interbody devices with Ti-Bond® coating for use in the cervical spine.
Spinal Element’s Ti-Bond coating consists of titanium with random, unconnected pores that is mechanically adhered through a plasma vacuum spray process to the superior and inferior surfaces of its PEEK-OPTIMA® interbody implants. This results in a porous titanium bone-opposing surface while allowing for direct visualization of the fusion mass through the radiolucent PEEK material.
The clearance included the addition of Ti-Bond to the company’s Crystal® Cervical Interbody devices as well as their two stand-alone cervical implants – Mosaic® and Vertu® , a no profile stand-alone device.
The company plans to make the product available starting in the first quarter of 2015.
Spinal Elements is the leader in surface-modified interbody fusion devices, having first introduced TiBond in its lumbar products in 2012. The company has a full compliment of lumbar Ti-Bond coated devices, including PLIF, TLIF, and ALIF devices. The company additionally has clearance for Ti-Bond on laterally-placed implants and will begin introducing that platform later in the year as they dramatically expand their minimally invasive (MIS) surgical solutions.
Todd Andres, CEO of Spinal Elements, commented, “This clearance and launch further establish Spinal Elements’ lead in the advancement of new technologies and materials in the interbody spinal fusion space and will help fuel the excitement and growth we have seen related to our Ti-Bond devices.”
Jason Blain, President of Spinal Elements, added, “We are glad to be able to expand our interbody offering to include Ti-Bond on devices for use in the cervical spine. We believe titanium-coated devices will become the standard choice of surgeons in the coming years and are glad to be the company that surgeons recognize as the leader in surface-modified fusion technology. This product introduction will join the multitude of MIS solutions that we will be introducing in 2015.”
About Spinal Elements
Spinal Elements, headquartered in Carlsbad, CA, is a spine technology company for spine surgeons who demand innovative, extremely high quality surgical solutions. From the company’s early work which helped make PEEK commonplace throughout the spine industry to recent advancements in Ti-Bond® coated interbody implants and controlled delivery technology, Spinal Elements has built a reputation for being trustworthy, innovative and different. The company is focused on the development and marketing of progressive spinal treatment options and markets a complete portfolio of advanced spinal implant technologies. Additionally, the company distributes Hero® Allograft, the net proceeds from which are donated to charities benefitting children with life-threatening medical conditions. For more information, please visit www.spinalelements.com.