Vy Spine to straighten its walk confidently with the FDA clearance for the VyBrate VBR System

Introduction

Vy Spine is a champion known for its exceptional designs and materials. This innovation leader was introduced to the healthcare sector via active internal development and the new qualified technologies that need innovative designs and materials. Overall, Vy Spine’s existence is based on the strong demand and development projects that will further fuel the global growth of the healthcare sector. The intensified products and new promising pro-level products are a huge support to surgeons and healthcare providers as well.

Announcement

Vy Spine proudly confirmed that the FDA have opened the gate for VyBrate VBR System at 510(k). This system is engineered to participate in thoracolumbar and cervical spine for vertebral body replacement surgery. This clearance has brought Vy Spine close to achieving a milestone in the innovative device space. This is a token of appreciation as the FDA trusts Vy’s potential to introduce more commendable innovations to the vast healthcare sector.

About VyBrate VBR

The VyBrate VBR is a creative device merging the osseointegration properties of the OsteoVy lattice structure and OXPEKK material, exclusive to Vy Spine. This best-in-class device is the first ever vertebral body replacement device to enter the market and boost the recognition with the help of OsteoVy PEKK, which is established in collaboration with Oxford Performance Materials.

President of Product Development at Vy Spine, Bret Berry, said, “This clearance from the FDA for VyBrate VBR is the recent news to take close to approvals for Vy Spine implants. Following this, the unique qualities will be performable to promote our exclusive OsteoVy PEKK designs at the core.”

“We are continuously researching the exceptional characteristics of OXPEKK, following which we have illustrated that this brilliant discovery is satisfying, but PEEK still feels short. Therefore, we’re expanding with OXPEKK material and continuing our valuable collaboration with Oxford Performance Materials.”

Difference between PEEK and OsteoVy lattice

PEKK implants are different from the standard PEEK implants, as the PEKK implants have recorded the bone ingrowth with no specific fibrotic tissue membrane formation, and radiographic interference. It has also illustrated a rise in bony apposition over time, and comparatively, a huge push-out power was spotted against PEEK. Alongside, Vy Spine’s exclusive OsteoVy lattice brings ease in bony wicking and integration, as PEKK is a hydrophilic material that holds more power as an interbody implant.