The problem–Facet Joint Syndrome (FJS)

FJS, also known as spinal osteoarthritis, spinal arthritis, or facet joint osteoarthritis, is a significant health and economic problem affecting millions each year. In 2011, Medicare and Medicaid patients alone accounted for approximately 1.8 million injections and RF Rhizotomyablations¹. Unfortunately a high number will have recurring symptoms requiring a follow up intervention each year. That’s because current treatment options are temporary and there is no proven long-lasting option for FJS.

The DenerveX™  system is different. It denervates and removes capsular tissue in one single procedure

Treatment results from the combined effect of a slow moving deburring or polishing action and RF ablation treatment. Using this new technique, the slowly rotating burr removes the targeted facet joint synovial membrane and joint surface while the electrocautery denudes any residual nervous and synovial membrane overlying the joint, effectively removing the end point sensory tissue of the joint.

Indications for Use:

DenerveX, in combination with the DenerveX Pro-40 RF Generator unit, is intended for coagulation of soft tissues in spinal applications for selective denervation and tissue destruction procedures, which may be performed on the lumbar, thoracic and cervical (C2-C7) regions of the peripheral nerves and nerve roots for the relief of pain associated with the facet joint.

* DenerveX is not currently CE Marked or commercially available in the United States of America.

Black Disc – Too far for conservative management but not ready to fuse…

Millions of people with degenerative disc disease (DDD) suffer from lower back pain but their condition is not so severe to require major fusion surgery. Conservative treatments and medication do not always provide adequate relief, so what are the options for these patients?

Disturbances in nutrient transport in degenerated discs lead to a buildup of lactic acid and pH levels as low as 5.75. The build-up of lactic acid alters cellular activity by down-regulating Proteogylcan (PG) synthesis and up-regulating enzymes that degrade the extracellular matrix. Low pH impairs the ability of PG to bind water. These factors lead to decreased hydration in the disc and further disturbances in nutrient transport.

There are very few options for patients with Symptomatic lumbar DDD other than conservative treatments or fusion.

FehrFix Hydrogel Implants

FehrFix is a nonsurgical treatment to treat discogenic pain in the early stages of Degenerative Disc Disease or when surgical intervention is undesirable or contraindicated. FehrFix introduces the hydrophilic material (hydrogel) into the disc nucleus and through volume expansion, restores natural hydration and pressure to degenerating discs as well as stabilizes the pH in the nucleus to healthier levels.

FehrFix hydrates through the absorption of the body’s own fluids, bringing lasting hydration and restoring pressure to the diseased disc and restoring it to a more desirable healthy state. The self-swelling hydrogel pins are made of a special hydrogel and use the osmotic principle to gain volume.

Preoperatively, FehrFix implants are in a dry, non-inflated state and holds that rigid form and shape until they are in direct contact with fluid. Once implanted into the disc nucleus, they absorb natural body fluids as they hydrate and expand continuously to a controlled and predefined size and shape (absorbing 10 times it’s own weight)

FehrFix Hydrogel Implants

  • Biocompatible and Biostable
  • Low Tissue Adherence
  • Permeable to water soluble compounds
  • Elasticity controlled by water
  • Strength & Elasticity comparable to tissues such as nucleus polposus & cartilage

The FehrFix Hydrogel Implant Procedure

  • Non-surgical intervention under local anaesthesia
  • Biocompatible elongated hydrogel implant
  • Inserted through a 17-gauge needle
  • Restores hydration and pressure to the diseased disc

FehrFix Clinical Information*

Patients generally see an improvement in pain very quickly and only have a little discomfort following the procedure

Dry State Status after swelling in NACl 0.9%
Weight (g) 0.019 0.275
Diameter (mm) 1.1 3.0
Length (mm) 14.5 36.7

Study 1

12 Patients

All with back and leg pain

10/13 (77%) Pain free or significant improvement

3 Patients required surgery (two after 6 months and one after 4 months)

Study 2

17 Patients

16 with back and leg pain plus 1 with leg pain 15/17 (88%) Pain free or significant improvement 2/17 could not have implants due to collapsed disc so had fusions

Indications

  1. Symptomatic lumbar DDD up to two segments.
  1. Dominant lumbar back pain with or without pseudo-radicular symptoms for more than 12 weeks, changes in MRI
  2. No improvement after minimum 12 week’s conservative treatment with physiotherapy and pain drugs.
  3. No age limit
  1. Visible disc changes on MRI
  1. Minimal facet degeneration
  1. Annulus should be largely intact, HIZ (high intensity zone) is not contraindicated
  1. VAS Pain Score >3

Contraindications

  1. Radiculopathy by nerve compression
  1. Stenosis, Spondylosis, Spondylolisthesis, acute fracture or Spondylitis at the treated segment.
  1. Modic type >2 or serious changes on endplates.
  1. Pregnancy

The Hydrogel is based on acrylic multi-block co- polymers that form a cross-linked hydrogel. The process is a simple partial hydrolysis chemical reaction that uses no monomers, cross-linkers, catalysts or other toxic residuals. Hydrogels have used in a wide range of medical applications for a couple of decades already. The applications are in areas of medicine such as Ophthalmology. Orthopaedic Surgery, Plastic Surgery, Heart Surgery, Gynaecology, Drug Delivery, Anaesthetics and Tissue Replacement.