Vertera Spine has announced that the company’s Coalesce lumbar interbody fusion device has received US Food and Drug Administration (FDA) 510(k) clearance for use in anterior, transforaminal, posterior, and lateral lumbar interbody fusion procedures.
The device features Vertera Spine’s proprietary porous PEEK biomaterial, and is the second porous PEEK device to receive FDA clearance behind the company’s Cohere cervical interbody fusion device.
Vertera Spine will be launching Coalesce for TLIF and PLIF procedures in multiple footprint, height, and lordotic angle configurations later this year.
Coalesce is designed to combines the osseointegration capabilities of porous metal implants with the favourable imaging and mechanical properties of traditional PEEK implants. Unlike metal-coated PEEK implants that can delaminate, Coalesce’s porous PEEK architecture is grown directly out of the implant’s solid PEEK base and has an interfacial strength stronger than the shear strength of vertebral trabecular bone.
Furthermore unlike 3D-printed metal implants, porous PEEK behaves mechanically similar to bone under compression, essentially eliminating any stress shielding effects, and does not produce any imaging artefacts enabling accurate visual assessment of fusion. Earlier this year, Spinal News International reported on research demonstrating better fusion rates for porous PEEK than microtextured titanium.
To date, over 2,000 Cohere devices have been successfully implanted with early successful clinical outcomes have been reported in a peer-reviewed publication.
“I initially became convinced of porous PEEK’s clinical benefits by the successful ACDF outcomes I obtained with the COHERE device,” says Gurvinder Deol, an early Cohere adopter from WakeMed Health and Hospitals in Raleigh, USA. “However, I believe porous PEEK’s true value will be demonstrated with the Coalesce device in lumbar procedures where the biologic fusion environment can be more challenging, and the biomechanics more demanding on fusion devices.”
Supported by research at Duke University, Durham, USA, and the Georgia Institute of Technology, Atlanta, USA, Coalesce’s porous PEEK architecture, with 60% porosity and 300mm average pore size, is tailored to elicit the optimal osteogenic cell response and promote bone tissue ingrowth inside the pores.
Ken Gall, chair of Mechanical Engineering and Materials Science at Duke University, presented new benchtop and clinical research on porous PEEK at the NASS Summer Spine Meeting (26–29 July; San Diego, USA).
According to Gall, “Our latest results show that porous PEEK is able to effectively osseointegrate by forming a mechanical and biological interface with bone. Our next steps are to translate what we have learned in animal models to the clinical setting by assessing this bony ingrowth into porous PEEK on X-Ray and CT.”