Spinal Elements, a spine technology company, has announced that they have received 510(k) clearance from the US Food and Drug Administration (FDA) to market an interspinous process device.
Interspinous process devices, placed between the spinous processes of the spine to provide support and fixation while a spinal fusion forms, can be less disruptive to the spine because minimal muscle and tissue retraction is required to surgically implant them. They are popular in the ambulatory surgical centre and outpatient spine markets.
Spinal Elements’ device includes enhancements that make it more accommodating to patient anatomy while streamlining the surgical procedure. Minimally invasive or conventional surgical techniques can be used to implant the device, which can be used in superspinous ligament-sparing or -sacrificing approaches.
Todd Andres, CEO and co-founder of Spinal Elements, said: “This clearance is another indicator of our relentless pursuit of solutions demanded by our surgeon customers. This device addresses part of our strategy to become the first choice of surgeons in both hospital and outpatient surgery settings.”
The company plans to begin clinical procedures with the interspinous process devices later this year with an initial launch in early 2017.
Spinal Elements has announced that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) to market a line of expandable interbody fusion devices.
A comprehensive list of items were a part of this clearance, including expandable interbody devices for posterior, anterior and lateral access to the lumbar spine. The expandable interbody devices are placed in the intervertebral space of the spine at a collapsed height and expanded vertically to increase in height. Additionally, the posteriorly placed and anteriorly placed devices can increase in lordotic angle during expansion, and the laterally placed devices can change coronal tilt during expansion.
The expandable devices will be made primarily from radiolucent PEEK material and feature Spinal Elements’ Ti-Bond® porous titanium coating at the endplate-contacting surfaces. PEEK has material properties that allow it to be a more load-sharing material in comparision with other popular implant materials such as titanium alloy. Spinal Elements’ Ti-Bond coating has been successfully used since 2012 in almost 10,000 implants and offers a roughened titanium surface for contacting the vertebral endplates.
Hyun Bae, medical director at The Spine Institute and professor of surgery at Cidars-Sinai Medical Center in Los Angeles, said: “I’m excited to get this device into a clinical setting as I believe the application of the device will help me address the needs of my patients. The ability of the device to expand as well as increase lordosis post-implantation will help me achieve saggital balance from a posterior approach unlike other devices I’ve experienced.”
The company plans to begin clinical procedures with the expandable devices later this year with an initial launch early next year.