Amsterdam International Co. | Replication
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Replication Medical develops and manufactures a broad portfolio of implantable medical devices based on its proprietary hydrogel platform technology. 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.

GelGuard™ Spinal Barrier

Posterior spinal surgery often leads to postoperative fibrosis, or scar formation. Nerve roots may be tethered to surrounding tissue or the spinal cord compressed with dense fibrotic scarring. Failed Back Surgery Syndrome (FBSS) is a term used to describe spine surgery cases in which pain symptoms are not relieved. The reported occurrence of FBSS varies widely, but the presence of fibrosis has been described in as much as 24% of these patients1. Approximately 15% of lumbar spinal surgery patients will require a reoperation within 5 years2.

GelGuard™ Spinal Barrier has been developed as a reconstructive barrier that protects against fibrosis migration following posterior spine surgery. The GelGuard™ also provides an easily identifiable plane of dissection during revision and adjacent level surgeries.

  • Flexible and smooth hydrogel sheet
  • Outstanding biocompatibility
  • Requires no prep time
  • Prevents tissue ingrowth following posterior spine surgery
  • Provides a plane of dissection for revision and adjacent level surgeries


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
Size offerings  
IPD-08 8mm
IPD-10 10mm
IPD-12 12mm
IPD-14 14mm
IPD-16 16mm

GelStix

he GelStix™ Nucleus Augmentation Implant provides a ground-breaking approach for treating lower back pain associated with degenerative disc disease and aging. Through volume expansion, the implant is intended to gently restore pressure and hydration to the nucleus pulposus.

Currently, millions of people with age-related degenerative disc disease suffer from low back pain but want to avoid major surgery. When conservative care and medication do not provide adequate relief, nonsurgical treatment options like GelStix™ may be of benefit.

 

  • Biocompatible elongated hydrogel matchstick
  • Non surgical intervention under local anesthesia
  • Inserted through the same 18 gauge needle used to administer intradiscal medication
  • Restores hydration and pressure to the diseased disc

Post-market studies show patients treated with GelStix™ experience improvement in visual analog and significant decreases in Oswestry at 6 months or greater.

EnGuard

The EnGuard™ Vessel Guard reduces the risk of potential vessel damage during a revision surgery by providing a plane of dissection and preventing scarring of blood vessels to the surrounding tissue and bone.

Vessel protection is particularly important in revision procedures where damage to the vena cava or aorta can lead to catastrophic results including death and limb loss. The implant is used in conjunction with anterior fusion and/or total disc procedures of which there are more than 300,000 performed annually in the United States and Europe alone.

  • Smooth and soft hydrogel supported by fabric
  • Flexible and superior handling characteristics
  • Outstanding biocompatibility
  • Requires no prep time
  • Affixed to surrounding soft tissue or vertebrae using sutures, staples, or tacks
Size offerings
VGCE-100065 100mm × 65mm
VGCE-065045 65mm × 45mm

Refer to the instructions for use supplied with the product for specific information regarding the use of this product.