This device is labeled as MR Conditional. This means that the device has a demonstrated safety in a specified MRI environment with the defined conditions of use listed. The information on this page provides only a summary of MR conditions and is intended as a reference for the U.S. only. For a full version of conditions, please see product Instructions for Use (IFU).
The information on this page is current as of November 2022. For the most current and complete MR safety information on any product, always refer to the IFU at eifu.goremedical.com.
GORE® CARDIOFORM Septal Occluder
|MR status||MR Conditional|
|Static magnetic field strengths||1.5 tesla or 3.0 tesla only|
|Maximum spatial gradient||4000 gauss/cm (40 T/m)|
|Max whole-body-averaged specific absorption rate (SAR)||4 W/kg (first level controlled operating mode)|
|Scan duration||15 minutes of scanning (i.e., per pulse sequence)|
|Image artifact (3 tesla, gradient echo pulse sequence)||In non-clinical testing, the image artifact caused by the GORE® CARDIOFORM Septal Occluder extends approximately 10 mm from this implant.|
|Time (post-implant) to safely scan||No restrictions listed in IFU|
INDICATIONS/INTENDED USE: The GORE® CARDIOFORM Septal Occluder is a permanently implanted device indicated for the percutaneous, transcatheter closure of the following defects of the atrial septum: ostium secundum atrial septal defects (ASDs); patent foramen ovale (PFO) to reduce the risk of recurrent ischemic stroke in patients, predominantly between the ages of 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke. CONTRAINDICATIONS: The GORE® CARDIOFORM Septal Occluder is contraindicated for use in patients: unable to take antiplatelet or anticoagulant medications such as aspirin, heparin, or warfarin; with anatomy where the GORE® CARDIOFORM Septal Occluder size or position would interfere with other intracardiac or intravascular structures, such as cardiac valves or pulmonary veins; with active endocarditis, or other infections producing bacteremia, or patients with known sepsis within one month of planned implantation, or any other infection that cannot be treated successfully prior to device placement; with known intracardiac thrombi. Refer to Instructions for Use at eifu.goremedical.com for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. RX Only