Information for U.S. Patients and Healthcare Providers
With any surgery, there are potential risks of complications. Barricaid Instructions for Use provides the FDA-approved instructions, indications/contraindications, warning, precautions, information for prescribers and summary of clinical data associated with the Barricaid Annular Closure treatment.
MRI SAFETY INFORMATION
Non-clinical testing demonstrated that the Intrinsic Therapeutics Barricaid device is MR Conditional. A patient with this device can be scanned safely in an MR system immediately after placement under the following conditions:
- Static magnetic field of 1.5-Tesla and 3-Tesla, only
- Maximum spatial gradient magnetic field of 3000 Gauss/cm or less
- Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2-W/kg for 15 minutes of scanning in the Normal Operating Mode of operation for the MR system
Under the scan conditions defined, the Intrinsic Therapeutics Barricaid Device is expected to produce a maximum temperature rise of 1.6˚C after 15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the Intrinsic Therapeutics Barricaid Device extends approximately 15 mm from this implant when imaged using a gradient echo pulse sequence and a 3-Tesla MR system.