Vertera Spine received FDA clearance for its COALESCE porous PEEK Lumbar Interbody Fusion Device.
Here are five points:
1. The FDA cleared the device for use in anterior, transforaminal, posterior and lateral lumbar interbody fusion procedures.
2. Vertera plans to offer COALESCE for TLIF and PLIF in various footprint, height and lordotic angle configurations in late 2017.
3. COALESCE features the company's porous PEEK biomaterial, offering an interfacial strength stronger than vertebral trabecular bone.
4. The porous PEEK material also mirrors bone in mechanical reaction to compression.
5. The COALESCE launch follows that of Vertera Spine's COHERE Cervical Interbody Fusion Device. Surgeons have implanted more than 2,000 COHERE devices, with early successful clinical outcomes.