Vistafix

Cochlear Bone Anchored Solutions AB

Craniofacial bone screw, non-bioabsorbable, sterile

The Cochlear prior generation Vistafix System and Vistafix 3 System are implant systems for facial prosthetics. The systems include osseointegrated titanium implants and titanium abutments that protrude through the skin. A Vistafix prosthesis is worn on the head. Cochlear Vistafix implants offer patients a high level of MRI compatibility. These guidelines are intended for radiologists performing MRI scans on a patient with a Cochlear Vistafix System. Please read this information carefully. For more information, contact Cochlear. As long as the Vistafix prosthesis, bar construction, any fixation magnets, magnabutments or magnacaps are removed for the MRI procedure, a patient fitted with a Vistafix System may be exposed to an MRI examination. When undergoing an MRI, the following conditions apply. The prosthesis, the bar construction, any fixation magnets, magnabutments or magnacaps attached to the implants must be removed before entering a room where an MRI scanner is located. Non-clinical testing has demonstrated that Vistafix implants, cover screws, and abutments are MR Conditional at 1.5 and 3.0 Tesla. They can be scanned safely under the following conditions. Scanning under other conditions may result in severe patient injury or device malfunction. MR System manufacturers may claim that scanning patients with implanted devices is generally contraindicated. This is a general precautionary claim due to the fact that MR System manufacturers are unable to ensure safety for all types of implantable devices. Cochlear has performed specific testing for the above implants and established the necessary SAR safety limits as outlined. Recently available MR Systems are able to monitor SAR levels. The MR System manufacturer should be able to provide advice on how to maintain SAR levels with their system. For further assistance on scanning patients with Vistafix Systems, call our MRI Information Line at: 1-866-210-9217.