We are driven to provide our clients with quality, long. Duraguard dural repair patch, preclude dura substitute, and codman ethisorb dura patch were evaluated in a sixmonth dural tissue reaction study in rabbits. Cardiovascular catheters, other catheters, and accessories more. Searchable database of fda 510k applications and descisions. 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.
We are driven to provide our clients with quality, longdated products in oem packaging at the lowest achievable prices. Duraguard dural repair patch, preclude dura substitute, and codman ethisorb dura patch were evaluated in a sixmonth dural tissue reaction study in. Patient had implant of synovis dura guard dural repair patch during craniotomy surgery. The invisx cranial fixation system is a unique, twosided clamping cranial fixation device used for skull flap replacement following a craniotomy procedure. On b6 2012, the dura guard patch culture was reported positive for aspergillus fumigatus. Use of an absorbable synthetic polymer dural substitute for repair. With the limited data available to synovis from the hospital, no further investigation can be performed. 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. Dg0404sn baxter synovis duraguard dural repair patch with apex 4. Failure to rinse the product may result in a sterile inflammatory reaction.
Repair of the dura after cranial neurosurgery can present a technical. Additionally, due to reduced fedex service, the cut off to place orders to ship same day ground has been moved to 1. This represents suturable technique that theoretically provides better watertight dural closure. Dura flow chronic dialysis catheter angiodynamics, inc.
Value analysis brief evidence for synthecel dura repair. Biocompatibility evaluation of dura mater substitutes in an. New synovis dg 0608sn each surgical dura guard dural repair. Dura guard offers advantages over competitive dural patches produced from autologous or cadaver tissue. Recall of duraguard dural repair patch international medical. Synovis surgical duraguard dural repair patch 6 cm x 8 cm add to wishlist. If required, limited patch repositioning is possible if performed immediately at this stage. Repair of the dura mater with processed collagen devices. Multiple attempts to obtain further info from the hosp have been unsuccessful.
Duraguard dural repair patch is prepared from bovine pericardium which is crosslinked with glutaraldehyde. Clinicallyproven products allow surgical teams freedom to innovate and think creatively without restraint in the operating room. Duraflex suturable graft competitive sell sheet integra. Repair of the dura after cranial neurosurgery can present a technical challenge and, for certain neurosurgical procedures, is critical to prevent cerebrospinal fluid leak and associated wound complications. Peri guard is not designed, sold or intended for use except as indicated. Recall of duraguard dural repair patch according to u. Fda 510k applications for medical device product code gxq dura substitute. The timesh system is a full line of plates, screws and meshes for use in bony. Biocompatibility evaluation of dura mater substitutes in an animal. On b6 2012, the pt was taken back to the operating room and the dura guard patch was removed and cultured. Baxter synovis duraguard dural repair patch with apex 4. Dura guard, dural repair patch with apex processing. However, based on the results of the synovis investigation, there is no reason to attribute the explant event to the dura guard patch. Aim for a minimum 1cm margin from suture line to the edge of the patch.
Duragen versus duraguard in chiari surgery full text view. Duragen did not maintain its structural integrity beyond 1 month. Dura guard dural repair patch is chemically sterilized using ethanol and propylene oxide. After an adequate intradural decompression the duraplasty was performed with either duragen or dura guard depending on randomization. Duraguard dural repair patch synovis life technologies.
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. About duraguard prod 4253 dura guard dural repair patch is derived from bovine pericardium and is indicated for use as a dural substitute. Recall of duraguard dural repair patch medicaldevices. Dura guard dural repair patch, preclude dura substitute, and codman ethisorb dura patch were evaluated in a sixmonth dural tissue reaction study in rabbits. Event type malfunction event description two 2 postcraniotomy patients developed post procedural abscesses at surgical site where dural patches. Tisseel fibrin sealant tisseel fibrin sealant accessories. Dura guard dural repair patch is available in five sizes.
Duraguard dural repair patch is chemically sterilized using ethanol and propylene oxide. Dura guard is chemically sterilized using ethanol and propylene oxide. Baxter, dg0814sn, synovis duraguard dural repair patch. Dura guard 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. Developed infection with pseudomonas aeruginosa approximately seven weeks later. Zerris va1, james ks, roberts jb, bell e, heilman cb. Dura guard 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, sterile, and. One material duragen is a nonsuturable collagen matrix that is applied over the defect if brain coverings dura. We are a liquidator of sutures and other surgical items from ethicon, covidien autosuture, synthes, stryker, arthrex and are able to pass our savings on to you. Integra bovine pericardium dural graft is a natural, resorbable, collagenous device for use in the repair of dura mater. Durepair was populated by fibroblasts and blood vessels, whereas dura.
Duraguard dural repair patch, preclude dura substitute, and codman ethisorb dura patch were evaluated in a sixmonth dural. The three dural substitutes tested were found to be safe and effective in healing surgically created defects in the dura mater. Dura guard patches were sutured to the native dura in a watertight fashion using 40 nurolon running nonlocking suture, whereas duragen was placed over the dural opening without any sutures or glue. Hold a damp swab over the patch, encouraging contact with tissue surface for 60 seconds. Medicare hcpcs c codes for reporting devices on hospital outpatient claims 2017 edition overview cms medicare requires the reporting of device c codes for certain outpatient procedures. Dura guard dural repair patch synovis surgical innovations 1. Duraguard dural repair patch synovis life technologies inc. Use of an absorbable synthetic polymer dural substitute. Baxters portfolio of products and programs are foundational to the cadence of surgery, just as surgeons, nurses, and administrators are essential to the art of healing. Dura guard is intended for use as a dura substitute for the closure of dura mater during neurosurgery. Tissuepatchdural is a surgical sealant film, specifically designed to reinforce closure of the dura mater to achieve a watertight seal. Duragen plus matrix readily conforms to the surface of the brain. Accurx constant flow implantable pump and duracath intraspinal catheter more.
Mar 29, 2018 accessgudid duraguard dural repair patch 00085412531007 duraguard is prepared from bovine pericardium which is crosslinked with glutaraldehyde. 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 products is an oem manufacturer of commercial and industrial lighting fixtures as well as many other electrical products. Baxter, dg0814sn, synovis duraguard dural repair patch with. Medicare hcpcs c codes for reporting devices on hospital. For use as a dura substitute for the closure of dura mater during neurosurgery.
Periguard is intended for repair of pericardial structures and for the surgical repair of soft tissue deficiencies which include. Dura guard is not designed, sold or intended for use except as indicated. Biocompatibility evaluation of dura mater substitutes in. Baxter, dg1016sn, synovis duraguard dural repair patch. Duraguard dural repair patch is packaged in a container filled with sterile, nonpyrogenic water containing propylene oxide. We construct our products with premium diecast and extruded aluminum bodies, and supply them standard with a chromate conversion coating under the powdercoat finish. In conclusion, subdural implantation of dura guard dural repair patch, preclude dura substitute, or codman ethisorb dura patch in rabbits for up to six months resulted in the eventual restoration. Aug 26, 2008 the study evaluates two materials used for duraplasty of the posterior cranial fossa in treatment of chiari malformation. Evidence for synthecel dura repair depuy synthes companies 3 value analysis brief. Duragen plus matrix is also indicated as an adhesion barrier for the inhibition of postsurgical peridural fibrosis. Dura guard dural repair patch when used to replace the dural membrane.
It is a selfadhesive film comprising synthetic polymers that are encountered in everyday surgery. Dura guard dura guard, a dural repair patch, is primarily used in craniotomy procedures when the dura must be repaired and suturing without a patch is not deemed sufficient. The denaturation temperature of durepair was comparable with the values reported for native collagens. Bilateral craniotomy was followed by subdural implantation for each dura mater substitute. Durepair regeneration matrix is a nonsynthetic dura substitute used to repair defects in the dura.
Inhouse fabrication and powder coating, two of our many services, are part of the reasons we can offer you greater. New synovis dg 0608sn each surgical dura guard dural. Baxter, dg0404sn, synovis duraguard dural repair patch. Accessgudid duraguard dural repair patch 00085412531007 duraguard is prepared from bovine pericardium which is crosslinked with glutaraldehyde. Use of an absorbable synthetic polymer dural substitute for. Dura guard dural repair patch by synovis surgical is an ideal substitute for cranial and spinal dural repair. Mn, usa, duragen integra north america, plainsboro, nj, usa, duraguard.
Jan 29, 2018 repair of the dura after cranial neurosurgery can present a technical challenge and, for certain neurosurgical procedures, is critical to prevent cerebrospinal fluid leak and associated wound complications. Accessgudid dura guard dural repair patch 00085412531007 dura guard is prepared from bovine pericardium which is crosslinked with glutaraldehyde. A list of current device category codes can be found on the. The pericardium is procured from cattle originating in.
Dura guard is prepared from bovine pericardium which is crosslinked with glutaraldehyde. Baxter, dg0608sn, synovis duraguard dural repair patch. Advancing the art of healing baxter specialty site. Infection control dept is reporting due to request from dept of health and cdc to report any infections with use of the dura guard dural repair patch. Apr 26, 2007 duragen did not maintain its structural integrity beyond 1 month. Bilateral craniotomy was followed by subdural implantation for each dura mater su. The device is derived from bovine pericardium and is manufactured using a multistep proprietary process which gently cleans and dehydrates the tissue. Dura guard has been treated with 1 molar sodium hydroxide for 6075 minutes at 2025c. The pericardium is procured from cattle originating in the united states.
Duragen plus adhesion barrier matrix integra lifesciences. The need in dural graft suturing in chiari i malformation. Synovis surgical dura guard dural repair patch 6 cm x 8 cm add to wishlist. Duraguard dural repair patch 00085412530987 duraguard is prepared from bovine pericardium which is crosslinked with glutaraldehyde. When you order our fixtures, you expect quality, and we deliver it. Duraguard duraplasty the duraguard patch is applied over the dural defect during. Surgishop is a thirdparty distributor of highend surgical disposables and endomechanical devices. The contents of the unopened, undamaged container are sterile. Fedex is experiencing unavoidable service delays due to covid19 which may impact the delivery of packages. Baxter, dg1016sn, synovis duraguard dural repair patch with.
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. The surgical procedure for the sham control group was the same except that no material was implanted. Duragen versus duraguard in chiari surgery full text. Dura guard dural repair patch is packaged in a container filled with sterile, nonpyrogenic water containing propylene oxide. Food and drug administration, this recall involved a device in united states that was produced by synovis surgical innovations, inc. Dura guard has been treated with 1 molar sodium hydroxide for.
Multiple options exist for dural repair, including. Duraguard duraplasty the duraguard patch is applied over the dural defect during chiari decompression surgery and sutured to the dural edge. This process helps protect the fixture and the paint finish from premature weathering, by increasing the. Durepair was populated by fibroblasts and blood vessels, whereas dura guard was not. Baxter synovis dura guard dural repair patch with apex 4. The denaturation temperature of duragen and dura guard differed significantly from that reported for native collagens. Tachosil absorbable fibrin sealant patch tissueguard family of surgical patches.
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