FehrFix Hydrogel

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

Contraindications

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

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