Evidence for synthecel dura repair a timeline of the evolution of technological advancement, research, and practice patterns in dura replacement is presented in figure 1. We currently do not have this item in stock, but we can email you as soon as it is available. Synovis surgical duraguard dural repair patch 6 cm x 8 cm add to wishlist. Bovine pericardium, apex processing, strong durable antilogouslike biological patch. Baxter, dg0404sn, synovis duraguard dural repair patch with. Duragen dural graft matrix,more than a patch, duragen is a matrix for repair of the dura mater. However, scores did not significantly differ between groups at the final follow up figure 1. Feb 27, 20 dura guard patients compared with duragen showed more improvement in quality of life at month 2. Duragen versus duraguard in chiari surgery full text view. Recall of duraguard dural repair patch international medical. This represents suturable technique that theoretically provides better watertight dural closure. Your choice of graft duraguard dural repair patch duraflex suturable dural graft vs non chemically crosslinked4 multistep proprietary process which gently cleans and dehydrates the tissue crosslinked with gluteraldehyde1 duraguard is chemically sterilized using ethanol and propylene oxide simple packaging5 supplied dehydrated. Peri guard is intended for repair of pericardial structures and for the surgical repair of soft tissue deficiencies which include. Duraguard the duraguard patch is applied over the dural defect during chiari decompression surgery and sutured to the dural edge.
Durepair was populated by fibroblasts and blood vessels, whereas duraguard was not. Bilateral craniotomy was followed by subdural implantation for each dura mater substitute. Baxter, dg0814sn, synovis duraguard dural repair patch. Duraguard dural repair patch, preclude dura substitute, and codman ethisorb dura patch were evaluated in a sixmonth dural. Baxter, dg0814sn, synovis duraguard dural repair patch with. Evidence for synthecel dura repair depuy synthes companies 3 value analysis brief. For dura guard dural repair patch, a nonabsorbable material derived from bovine pericardium, the implantation site was characterized by fibrosis of the overlying area with islands of osseous. Class 2 device recall duraguard dural repair patch, synovis baxter figure. Synovis duraguard dural repair patch with apex 4cm x 4cm.
Duragen secure matrix is indicated as an only graft for the repair and restoration of dural defects in cranial and spinal surgical procedures. Duraguard dural repair patch is packaged in a container filled with sterile, nonpyrogenic water containing propylene oxide. The use of surgical sealants in the repair of dural tears. Although it is a rare complication, the dura may get injured or tear during spinal surgery resulting in the leakage of cerebrospinal fluid csf, which normally surrounds the brain and spinal cord. Periguard is intended for repair of pericardial structures and for the surgical repair of soft tissue deficiencies which include. The team at duraguard place a strong emphasis on safety, quality and our impact on the environment and have proven ourselves as industry leaders time and time again in some of the most demanding and complex work environments.
The dura mater is a tough, fibrous membrane that surrounds and protects the tissues of the brain and spinal cord. Pdf dural repair in cranial surgery is associated with. Duraguard dural repair patch synovis surgical innovations 1. Duragen plus matrix is also indicated as an adhesion barrier for the inhibition of postsurgical peridural fibrosis. Aug 26, 2008 duraguard duraplasty the duraguard patch is applied over the dural defect during chiari decompression surgery and sutured to the dural edge. If required, limited patch repositioning is possible if performed immediately at this stage. Duraguard dural repair patch synovis life technologies inc. Dural repair is primarily performed for head and spinal injuries where a laceration has occurred to the dura, and for neurosurgical procedures in which the dura is required to be opened or removed to gain access to the bones or delicate tissues within.
The pericardium is procured from cattle originating in the united states. Value analysis brief evidence for synthecel dura repair. Dura guard dural repair patch is available in five sizes. A heritage of healing advancing the art of healing baxter. Duracath intraspinal catheter 316l ss, silicone advanced neuromodulation systems plano, tx. Duraguard is chemically sterilized using ethanol and propylene oxide. The timesh system is a full line of plates, screws and meshes for use in bony reconstruction after cranial neurosurgical procedures. Inhouse fabrication and powder coating, two of our many services, are part of the reasons we can offer you greater. Duraguard patch dural repair neurosurgery 2 cm x 9 cm dg0209sn 4 cm x 4 cm dg0404sn 6 cm x 8 cm dg0608sn 8 cm x 14 cm dg0814sn 10 cm x 16 cm dg1016sn periguard patch pericardial, intracardiac, great vessel and septal defects, soft tissue deficiency repairs and suture line buttressing abdominal surgery thoracic surgery.
Duraguard has been treated with 1 molar sodium hydroxide for 6075 minutes at 20. Dural repair or other spinal cord repair the spinal cord is covered by three layers of tissue called meninges, the outermost being the dura mater. Dura guard dural repair patch when used to replace the dural membrane. Manufacturer section d synovis surgical innovations. The local inflammation response to synthecel two weeks after implantation was similar to that of duragen and less than that of duraguard dural repair patch figure 6. Class 2 device recall duraguard dural repair patch fda.
Duraguard dural repair patch synovis life technologies. Duraguard is packaged in a container filled with sterile, nonpyrogenic water containing propylene oxide. For duraguard dural repair patch, a nonabsorbable material derived from bovine pericardium, the implantation site was characterized by fibrosis of the overlying area with islands of osseous. Duragen did not maintain its structural integrity beyond 1 month. Dura guard dural repair patch is packaged in a container filled with sterile, nonpyrogenic water containing propylene oxide. Duragen secure dural regeneration matrix is an absorbable implant for the repair of dural defects. For use as a dura substitute for the closure of dura mater during neurosurgery. Bilateral craniotomy was followed by subdural implantation for each dura mater su. This indicates that dura guard patients may recover more quickly but duragen patients reach a comparable quality of life at 3 months postoperatively. The contents of the unopened, undamaged container are sterile duraguard dural repair patch device characteristics. Duragen versus duraguard in chiari surgery study results. Duraguard dural repair patch synovis surgical innovations. Biocompatibility evaluation of dura mater substitutes in an animal.
Dura guard, dural repair patch with apex processing. Is an innovative collagen matrix for dural closure. Duragen secure dural regeneration matrix is an easy to handle, soft, pliable, nonfriable, porous collagen matrix with an antimigration layer hydroxypropyl metlhycellulose hpmc that, when used as directed, reduces the risk of product migration or displacement, e. Dg0608sn synovis surgical duraguard dural repair patch 6. Aim for a minimum 1cm margin from suture line to the edge of the patch. Synovis duraguard dural repair patch with apex 8cm x 14cm. Heres the part of the report about the graft, attention was directed to the repair. In our experience, a single, very thin layer of bioglue is sufficient to reinforce the dural repair site and to prevent any secondary ruptures. The timesh system is a full line of plates, screws and meshes for use in bony. Duraguard products is an oem manufacturer of commercial and industrial lighting fixtures as well as many other electrical products. Duraguard has been treated with 1 molar sodium hydroxide for. It is indicated for use as a suturable dura membrane for the repair of the dura mater and requires only a short rehydration. Duragen secure matrix readily conforms to the surface of the brain, spinal cord and overlying tissues.
Duragen handles and conforms similar to normal soft tissue. The local inflammation response to synthecel two weeks after implantation was similar to that of duragen and less than that of dura guard dural repair patch figure 6. Duraguard dural repair patch is available in five sizes. Mar 29, 2018 accessgudid duraguard dural repair patch 00085412531007 duraguard is prepared from bovine pericardium which is crosslinked with glutaraldehyde. A heritage of healing advancing the art of healing. Duraguard dural repair patch is chemically sterilized using ethanol and propylene oxide. Posterior cranial fossa repair and enlargement with application of dural patch duraguard. Processed bovine pericardium as patch angioplasty for carotid endarterectomy. Remarkable onlay graft for the repair of dural defects. Your choice of graft duraflex vs integra lifesciences. The need in dural graft suturing in chiari i malformation.
Dural repair patch 6 cm x 8 cm, market implantable biomaterials and other devices for use in critical surgical applications including bariatric, thoracic, cardiac, neurosurgical, vascular and general surgeries. Dura guard dural repair patch is chemically sterilized using ethanol and propylene oxide. The surgical procedure for the sham control group was the same except that no material was implanted. Us market report for dural repair 2017 medcore gii. Duraguard dural repair patch by synovis surgical is an ideal substitute for cranial and spinal dural repair. The initial strength, stiffness, and suture retention force were. Recall of duraguard dural repair patch medicaldevices. Duragen plus adhesion barrier matrix is indicated as an onlay graft for the repair and restoration of dural defects in cranial and spinal surgical procedures. Fully resorbed following complete tissue closure of the dural,medicine,medical supply,medical supplies,medical product. We have engineered collagen dural repair products that are csf leak resistant and which have collagen scaffold properties that allow for native dural tissue to naturally regenerate resulting in the protection, closure and repair of dural defects. Duragen plus adhesion barrier matrix integra lifesciences. Surgishop is a thirdparty distributor of highend surgical disposables and endomechanical devices. Dg0608sn synovis surgical duraguard dural repair patch.
Repair of the dura mater with processed collagen devices. Durepair was populated by fibroblasts and blood vessels, whereas dura guard was not. Duraguard patch dural repair neurosurgery 2 cm x 9 cm dg0209sn 4 cm x 4 cm dg0404sn 6 cm x 8 cm dg0608sn 8 cm x 14 cm dg0814sn 10 cm x 16 cm dg1016sn periguard patch pericardial, intracardiac, great vessel and septal defects, soft tissue deficiency repairs and suture line buttressing. Duraguard is prepared from bovine pericardium which is crosslinked with glutaraldehyde. Duragen plus matrix readily conforms to the surface of the brain. Accessgudid duraguard dural repair patch 00085412531007 duraguard is prepared from bovine pericardium which is crosslinked with glutaraldehyde. The biodesign dural repair graft showed better workability than the porcine pericardial patch, which was more transparent p 0. The three dural substitutes tested were found to be safe and effective in healing surgically created defects in the dura mater. Duraguard patients compared with duragen showed more improvement in quality of life at month 2. Patient came to my dr for back pain, dr went in to do a microdiscectomy w repair of csf leak w dural graft. Hold a damp swab over the patch, encouraging contact with tissue surface for.
This indicates that duraguard patients may recover more quickly but duragen patients reach a comparable quality of life at 3 months postoperatively. Duragard angle profile corner protection angle profiles for subsequent installation easy assembly by gluing retrofitting made of stainless steel, aluminum, brass or pvc angle profiles in the duragard series are high quality corner protection profiles made of v2a stainless steel, aluminium, brass or pvc and can also be fitted subsequently thanks to their simple adhesive installation. Baxter, dg0404sn, synovis duraguard dural repair patch. Duraflow chronic dialysis catheter angiodynamics, inc. Jul 01, 2017 the dura mater is a tough, fibrous membrane that surrounds and protects the tissues of the brain and spinal cord. The invisx cranial fixation system is a unique, twosided clamping cranial fixation device used for skull flap replacement following a craniotomy procedure. Biocompatibility evaluation of dura mater substitutes in an. Dura guard dural repair patch synovis surgical innovations 1. The contents of the unopened, undamaged container are sterile.
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