The GelFix™ Interspinous Spacer is a one piece posterior spinal distraction implant made from RMI’s biocompatible hydrogel. Implanted between the spinous process through a small incision, GelFix™ acts as a dynamic spacer restricting painful motion without adversely affecting other segmental motion.
GelFix™ increases space between the spinous processes in order to maintain flexion. GelFix™ is composed of a viscoelastic material that yields and provides a “soft-stop” in extension. As a result of the intrinsic nature of the polymer, the potential for complications such as spinous process breakage and subsidence may be reduced.
- Non-rigid viscoelastic
- Unilateral insertion
- Minimally invasive procedure
- Preserves ligaments and tissue
About Interspinous Devices
Interspinous spacers sometimes also called as Interspinous process decompression systems, are the devices implanted between vertebral spinous processes. These spacers are made up of a very strong but lightweight metal (titanium) which is biocompatible in the human body. These devices are imbedded in body to confine painful motion else enabling normal motion and to treat lumbar spinal stenosis, discogenic low-back pain, facet syndrome, disc herniations, and non-traumatic instability. Lumbar spinal stenosis is a thinning of the spinal canal in the lower back which causes compression on nerves and it is developed gradually with age. Radiology tests are used to confirm a diagnosis of moderate degenerative lumbar spinal stenosis. People with lumbar spinal stenosis experience pain but may also have weakness in their leg, lower back and buttocks, numbness, tingling.
The Interspinous spacer are implanted between those vertebrae in such a way that it prevents the patient from bending too far backward which causes pain by surgical procedure. The procedure is very small and sometimes patient can go home within a day.The increasing prevalence of spinal stenosis due to aging, arthritis, heredity and increased demand of surgical procedures that improved lifestyle and comfort will drive the Interspinous spacer market. The adoption of spacers are increasing due to low complication rate as compared to decompression and spinal fusion. The Interspinous spacers are widely used in geriatric population as per Medicare data due to old age patient are not comfortable with surgery due to their health conditions. Source:Transparency Market Research (TMR)
About Replication Medical
Headquartered in Monmouth Junction, New Jersey in the United States, Replication Medical is a leader in the design and development of novel, biomimetic hydrogel implants providing ground breaking treatment options in a broad range of markets including spine, orthopedics, neuro, and vascular surgery. Replication Medical has over ten years of learning curve experience with its proprietary, biocompatible shape-memory hydrogel. While Replication Medical has focused on spine surgery related products, the underlying technology is a product engine with the potential to have significant impact on virtually any clinical arena.Replication Medical markets the EnGuard™ protective cover for spinal blood vessels in the US. Additional products are distributed outside the US including treatments for spinal stenosis (GelFix™), degenerative disc disease (GelStix™ GelStik™), and the prevention of epidural fibrosis (GelGuard™). Products in the development pipeline will address unmet needs in spine, orthopedics, neuro, vascular and other therapeutic areas.Quality is a key consideration in the design and development of all Replication Medical products. In keeping with its commitment to quality, the company is FDA registered and ISO 13485 certified.http://www.replicationmedical.com