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OmniPore® DUROMAX® Surgical Implants are intended for non-weight bearing applications of maxillofacial and orbital reconstruction, cosmetic surgery and repair of maxillofacial and orbital trauma.

The OmniPore DUROMAX Surgical Implants are an extension within the family of OmniPore Surgical Implants. OmniPore DUROMAX Surgical Implants include the addition of pure titanium within the porous high-density polyethylene. They are marketed as single use sterile implants with various sizes. The material used for the OmniPore DUROMAX Surgical Implants is a porous high-density (HD) polyethylene. Polyethylene has a long history of use in surgical implantable products. The interconnecting open pore structure of the implants allow for tissue ingrowth. Both of the materials used to manufacture the OmniPore DUROMAX Surgical Implants, the porous HD polyethylene and pure titanium, have been utilized in reconstruction and soft tissue repair for many years. There is a long history of the use of porous polyethylene and titanium implants for enucleation and evisceration, as well as for reconstruction/cosmetic surgery and repair of the orbital skeletal framework, including orbital floors, walls, rims and roof, with a history of safety and performance. The interconnecting open pore structure of the OmniPore DUROMAX Surgical Implants allow for tissue ingrowth. Additionally, animal histology has shown fibrovascular ingrowth occurs into the open pore structure of porous surgical implants. The other advantage to the OmniPore DUROMAX Surgical Implants is that the titanium structure can be curved or rounded and will hold that shape in the internal orbital skeletal framework. The titanium material contained in OmniPore DUROMAX Surgical Implant is also radiopaque on post-operative CT (computed tomography) scans. The implants are single use and provided sterile by ethylene oxide (EO) terminal sterilization.

OmniPore® Customized Surgical Implants are intended for non-weight bearing applications of craniofacial reconstruction/ cosmetic surgery and repair of craniofacial trauma. OmniPore Customized Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.

The OmniPore® Customized Surgical Implants are marketed as single patient use sterile implants that physicians request as customized surgical implants which use identical materials and manufacturing to the OmniPore® Surgical Implants but are made to a predetermined patient's measurements and size requirements. The applications include non-load bearing augmentation and/or reconstruction of the craniofacial skeleton. The OmniPore Customized Surgical Implants are created from the patient's CT imaging data provided from the physician. The OmniPore Customized Surgical Implants are manufactured from the same material, manufactured under the same processes, and packaged the same as the OmniPore Surgical Implants. The raw material used for the OmniPore Customized Surgical Implants is high-density polyethylene resin which has a long history of use in surgical implantable products. The interconnecting open pore structure of the OmniPore Customized Surgical Implants allow for tissue in-growth. Additionally, animal histology has shown fibrovascular in-growth occurs into the open pore structure of OmniPore Customized Surgical Implants. The implants are single use and provided sterile by ethylene oxide (EO) terminal sterilization.