FDA Clears COALESCE™ Porous PEEK Lumbar Interbody Fusion Device

Vertera Spine’s COALESCE™ Lumbar Interbody Fusion Device has been cleared by the U.S. FDA for use in anterior, transforaminal, posterior, and lateral lumbar interbody fusion procedures.

Background

Vertera Spine is a developer of medical devices using advanced biomaterial technologies.  Its COALESCE system features the company’s novel proprietary porous PEEK biomaterial and is the second porous PEEK device to receive FDA clearance behind Vertera Spine’s COHERE™ Cervical Interbody Fusion Device.

COALESCE combines the osseointegration capabilities of porous metal implants with the favorable 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 similarly to bone under compression, essentially eliminating any stress-shielding effects, and does not produce any imaging artifacts enabling accurate visual assessment of fusion.

Vertera Spine will be launching COALESCE for TLIF and PLIF procedures in multiple footprint, height, and lordotic angle configurations later this year.

Physician comments

“I initially became convinced of porous PEEK’s clinical benefits by the successful ACDF outcomes I obtained with the COHERE device,” said Gurvinder Deol, MD, an early COHERE adopter from WakeMed Health and Hospitals in Raleigh, NC. “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.”

Company comments

“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,” said Chris Lee, Vertera Spine CEO. “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.”

 

Source: Vertera Spine, Inc.

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