CRANBURY, N.J., March 8 /PRNewswire/ -- Replication Medical, Inc., a developer of proprietary, hydrogel based products for the spine and other surgical applications, announced today that it has received a CE mark for its GelFix Posterior Spinal Distraction implant. A CE mark is the quality assurance certification requirement recognized by members of the European Union for sales into those countries.
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 Food and Drug Administration (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 EnGuard Vessel Guard is the first in a series of innovative products based on their proprietary hydrogel technology that the company is launching this year in the United States.
Commenting on these developments, 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.
"Our products provide a technologically advanced alternative to the conventional metal and hard plastic implants which have dominated orthopedics and spine to date. Replication Medical looks forward to entering these markets because we offer the only technology which provides a biomimetic solution to treat these medical conditions," she explained.
The GelFix interspinous implant may not only reduce pain, but also increase the mobility of the patient. "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," said Carl Lauryssen, M.D., one of Replication Medical's surgeon advisors.
The GelFix Posterior Spinal Distraction Implant is not currently approved for sale or distribution in the United States.