DuraFuse™ Bioabsorbable Clips For Spinal DuraL Closure

Save time and money with DuraFuse Spinal Dural Clips, eliminate leakage from suture holes, reduce operative time, and avoid costly patches and sealants.

DuraFuse Bioasorbable clips for spinal duraL closure

Avoid penetrating devices that can cause CSF leakage, increased operative time, longer hospital stays, and costly patches and sealants.


Non-penetrating Solution for Spinal Closure

Avoid the risk of potential CSF leaks with suture and other penetrating devices.

DuraFuse Spinal Closure

Rapid. Simple. Secure.

Multiple clips can be deployed quickly for large dural openings, reducing operative time compared with suture.

DuraFuse

Frequently Asked Questions

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Indications: DuraFuse Clips are indicated for open and tubular retractor procedures of the spine in the prone position for approximation/attachment and/or closure of the dura mater in neurosurgical and orthopedic spine procedures.

Contraindications: DuraFuse Clips are contraindicated in the following situations:

  • For patients with a known sensitivity to bioabsorbable polymers such as
    bioabsorbable sutures
  • For repair of cranial dural tissue around the skull
  • Dural tissue cannot be properly everted due to anatomical limitations
  • Dural tissue is too friable for the use of sutures
  • Do not use DuraFuse Clips in sites with acute or chronic infections

Warnings:

  • Failure to appropriately evert the dural ends can result in improper closure, which can cause possible cerebrospinal fluid (CSF) leakage and/or neural tissue adhesions.
  • DO NOT over‐apply Clips or they may not form a seal. Too much dural tissue inserted into Clip opening can interrupt formation of a seal, allowing CSF to leak out of the closure site.
  • Clips should be placed together closely, but not directly touching. A gap of approximately 0.5 mm is acceptable.
  • Instrument breakage or damage, as well as tissue damage, may occur when an instrument is subjected to excessive loads, improper use, or unintended use.
  • Improper insertion of the device can lead to soft tissue complications.
  • The instruments are intended only for professional use by a licensed physician.

Adverse Effects:

  • Infection
  • Pain/swelling
  • Tissue damage
  • Blood leakage
  • Hemorrhage
  • Stenosis
  • Thrombosis/occlusion
  • Dehiscence
  • Necrosis
  • Seroma
  • Nerve injury
  • Steal phenomenon
  • CSF leak
  • Pseudomeningocele
  • Neuropathic pain
  • Spinal infarction

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