Vertera Spine has secured an approval from the US Food and Drug Administration (FDA) for its Coalesce lumbar interbody fusion device.
The approval is for using the device in anterior, transforaminal, posterior, and lateral lumbar interbody fusion procedures.
According to Vertera Spine, Coalesce features its novel proprietary porous PEEK biomaterial. It has now become the second porous PEEK device to get FDA approval after the company’s Cohere cervical interbody fusion device.
Vertera Spine CEO Chris Lee said: "Based on the initial success with the COHERE Cervical porous PEEK device, we saw the need to apply this innovative technology to other spine applications.
"We are pleased to have received FDA clearance for COALESCE and look forward to further serving surgeons' clinical demands for a durable fusion device that successfully osseointegrates and allows for integration to be assessed on imaging."
Coalesce is expected to be launched for TLIF and PLIF procedures in multiple footprint, height, and lordotic angle configurations in due course of the year.
Coalesce leverages on the osseointegration capabilities of porous metal implants and combines them with the favorable imaging and mechanical properties of conventional PEEK implants.
In contrast to metal-coated PEEK implants that are prone to delaminate, Coalesce’s PEEK architecture is grown directly out of the solid PEEK base of the implant. It also has an interfacial strength that is comparatively more than the shear strength of vertebral trabecular bone.
Also, when compared to 3D-printed metal implants, porous PEEK is mechanically similar to bone under compression. Thereby, it essentially removes any stress shielding effects, and does not create any imaging artifacts to allow for accurate visual assessment of fusion.
Image: The FDA Laboratory Building 62 in Silver Spring, Maryland which houses the Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration/Wikipedia.org.