NuVasive Update on COALESCE, COHERE Interbody Fusion Devices

By Julie A. Vetalice

NuVasive (NUVA) launched the COALESCE™ Thoracolumbar Interbody Fusion device, and announced FDA 510(k) clearance to market the COHERE® Cervical Interbody Fusion Device with expanded indications. NUVA gained ownership of these systems with its 3Q17 acquisition of Vertera Spine.

The devices join Modulus® Titanium interbodies in NUVA's Advanced Materials Science portfolio, offering implants whose architecture is intended to enhance osseointegration in ways not possible with solid implants.

COALESCE received FDA clearance at the close of 2Q17 for use in anterior, transforaminal, posterior and lateral lumbar fusion. In 4Q17, indications expanded to include use for one or two adjacent levels in the thoracolumbar spine with both autograft and allograft.

COHERE was the first clinically available device manufactured entirely out of PEEK, containing porosity. It received its initial 510(k) clearance in 2015. Newer expanded indications allow use at multiple levels in the cervical spine with both autograft and allograft. Further, COHERE is the only product approved for use with a specific ICD-10 code for a radiolucent porous interbody fusion device, which signifies CMS' recognition of the potential benefits of Porous PEEK technology.

Sources: NuVasive, Inc.; ORTHOWORLD Inc.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Product Launch, Regulatory