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Magnetic Resonance Imaging (MRI) Safety Information

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 February 2024. For the most current and complete MR safety information on any product, always refer to the IFU.

GORE® HELEX® Septal Occluder (Product has been discontinued)

MR statusMR Conditional
Static magnetic field strengths1.5 tesla or 3.0 tesla
Maximum spatial gradient720 gauss/cm
Max whole-body-averaged specific absorption rate (SAR)3.0 W/kg
Scan duration15 minutes of scanning
Image artifact (3 tesla, gradient echo pulse sequence)The 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® HELEX® Septal Occluder. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary.
Time (post-implant) to safely scanNo restrictions listed in IFU

Consult Instructions for Use symbol

INDICATIONS FOR USE: The GORE® HELEX® Septal Occluder is a permanently implanted prosthesis indicated for the percutaneous, transcatheter closure of ostium secundum atrial septal defects (ASDs). 
CONTRAINDICATIONS: The GORE® HELEX® Septal Occluder is contraindicated for use in patients: 

  • With extensive congenital cardiac anomalies that can only be adequately repaired by cardiac surgery

  • Unable to take anti-platelet or anticoagulant medications such as aspirin, heparin, or warfarin 

  • With anatomy where the GORE® HELEX® 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 

  • Whose vasculature is inadequate to accommodate one of the GORE® HELEX® Septal Occluder Recommended Introducer Sheaths 

  • With known intracardiac thrombi

Refer to Instructions for Use for a complete description of all applicable indications, warnings, precautions and contraindications for the markets where this product is available. RXOnly

Product has been discontinued and is not available in any market.