Replication Medical, Inc., a developer of proprietary, hydrogel-based products for the spine and other surgical applications, recently announced that it has received a CE mark for its GelFix Posterior Spinal Distraction implant.
The GelFix device is a one-piece posterior spinal implant made from HPAN, a biocompatible hydrogel which exhibits desirable mechanical properties, including compressive resistance with a dynamic response. The GelFix distraction implant is used as a spacer between the spinous processes to provide separation and prevent nerve pinching. The product is available in three sizes to fit the typical range of spinal stenosis patients.
The CE mark for this implant follows the approval the company received last year from the FDA to market its EnGuard™ Vessel Guard. The EnGuard device is indicated for use as a protective cover for blood vessels following anterior spine surgery and is composed of the same biocompatible polymer.
The GelFix interspinous implant works to reduce pain and increase patient mobility with a minimally invasive procedure. More information is available by contacting the company at firstname.lastname@example.org.