Replication Medical, a developer of hydrogel based products for the spine and other surgical applications, has received a CE mark for its GelFix Posterior Spinal Distraction implant.
New Jersey-based Replication’s 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 device not only reduces pain, but also increase the mobility of the patient. The product is available in three sizes to fit the typical range of spinal stenosis patients.
The CE mark for the implant follows the approval which the company has received previous 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.
Ann Prewett, president and CEO, said: “The GelFix implant provides a unique, minimally invasive solution for treating spinal stenosis, a leading cause of back pain. The GelFix device acts as a dynamic spacer, compressing under load yet maintaining separation of the interspinous space. In this manner, some of the complications associated with rigid spacers such as breakage of the bones of the spinous process or subsidence may be avoided.”
Carl Lauryssen, surgeon advisor at Replication Medical, said: “The key to the procedure is the minimally invasive technique which can be used to implant the device. We insert the implant between the appropriate spinous processes and in 8-10 hours, the implant increases in size and gives us the stability that we need.”