GORE® CARDIOFORM Septal Occluder
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 EMEA only. For a full version of conditions, please see product Instructions for Use (IFU).
The information on this page is current as of March 2025. For the most current and complete MR safety information on any product, always refer to the IFU at eifu.goremedical.com.
| MR Status | MR Conditional |
|---|---|
| Static magnetic field strengths | 1.5 or 3.0 Tesla only |
| Maximum spatial gradient | 720 gauss/cm (7.2 T/m) |
| Max whole-body-averaged specific absorption rate (SAR) | 3.0 W/kg |
| Scan duration | 15 minutes of continuous scanning |
| Image artifact (3 Tesla, gradient echo pulse sequence) | Image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the GORE® CARDIOFORM Septal Occluder |
| Time (post-implant) to safely scan | Immediately after placement |
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. RXOnly
INDICATIONS FOR USE IN EUROPE: The GORE® CARDIOFORM Septal Occluder is a permanently implanted device indicated for the percutaneous, transcatheter closure of atrial septal defects (ASDs), such as ostium secundum and patent foramen ovale.
CONTRAINDICATIONS: The GORE® CARDIOFORM Septal Occluder is contraindicated for use in patients:
- Unable to take anti-platelet 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.