PEEK-OPTIMA HA Enhanced implantable polymer gets 1st CE mark

Spinal Tech

The first implant made from PEEK-OPTIMA HA Enhanced implantable polymer received the CE mark of approval.

Karmed Saglik Group supplied the implants, which are designed to treat degenerative spinal conditions. The approval will allow the implant to be distributed in the European Union.

 

Here are a few quick facts about the implant:

 

• The clearance was granted for the Superfusion line of implants
• The implant line focuses on interbody cages for therapeutic use in the cervical and lumbar spine
• There is increased adoption of Invibio's PEEK-OPTIMA HA Enhanced inside and outside of Europe, according to the report.
• The U.S. FDA cleared a SpineFrontier implant in November using the polymer

 

"We selected the polymer because it pushes past the traditional boundaries of bone on-growth," said Gamze YILDIRIM, Business Development Manager at the Karmed Group. "We have been aware for some time that it is an exceptional performer in spinal fusion scenarios, enabling early and direct bone apposition. In fact it has many virtues, including radiolucency, enabling monitoring of the implant in a way that is just not possible with titanium implants."

 

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