60% of patients undergoing transcatheter ASD closure have been reported to have deficient retro-aortic rims.*,2  

In the Gore ASSURED Clinical Study, 56.4% of patients were reported to have deficient retro-aortic rims (≤ 5 mm) and were treated with the GORE® CARDIOFORM ASD Occluder.*,1 

The GORE® CARDIOFORM ASD Occluder achieved 100% closure success† at 36 months, with no reported incidents of cardiac erosion.1 

The GORE® CARDIOFORM ASD Occluder is a permanently implanted device indicated for the percutaneous, transcatheter closure of ostium secundum atrial septal defects (ASDs). 

Advanced materials delivering exceptional conformability †,‡,§,1

 

  • Developed by a company with 60 years of materials science experience
  • Engineered to conform to a broad range of ASD anatomies‡,1,3

  • No minimum retro-aortic rim requirements3

     

See available resources
GORE® CARDIOFORM ASD Occluder

Consistent safety outcomes ‡‡ across a broad range of ASD anatomies‡,1,3 

The Gore ASSURED Clinical Study results through 36 months continue to demonstrate 100% closure success with the GORE® CARDIOFORM ASD Occluder, and consistent safety outcomes across a broad range of ASD anatomies, including patients with deficient retro-aortic rims.*, †, ‡, ‡‡,1,3

  • 0 reported device erosions1
  • 100% effective closure across a broad range of ASD anatomies at 36 months†, ‡,1,3
  • 0 reported device embolizations or thrombus beyond 6 months1
  • 0 reported clinical sequelae due to wire frame fracture in the study1 
See more on ASSURED Study

Trusted deployment**,3 

 

  • Straightforward delivery with the ability to retrieve and reposition**, 3
  • Pre-assembled occluder and delivery system3 designed to reduce device preparation time 
Hand holding a GORE CARDIOFORM ASD Occluder with product features called out

The built-in retrieval cord allows for tension-free assessment and post-lock retrieval, if needed.3

Watch how the GORE® CARDIOFORM ASD Occluder is deployed 

    1-2-3 deployment sequence**,3 

    Related to this product

    * Deficient retro-aortic rim was defined as a retro-aortic rim measuring less than or equal to 5 mm on any view on echocardiogram.
    † Closure success defined as a clinical residual defect status of occluded or clinically insignificant as determined by the Echo Core Lab at the 36-month evaluation among subjects with technical success.  
    ‡ All ASD anatomies were eligible for inclusion into the ASSURED Clinical Study within indicated sizing parameters of the Instructions for Use. 
    § 100% closure success rate across ASD anatomies at 36-months.†, ‡ ,3
    llNickel titanium.
    Patients allergic to nickel may suffer an allergic reaction to the GORE® CARDIOFORM ASD Occluder. Certain allergic reactions can be serious; patients should be instructed to notify their physicians immediately if they suspect they are experiencing an allergic reaction such as difficulty in breathing or inflammation of the face or throat. Some patients may also develop an allergy to nickel if this device is implanted.  
    ** 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  
    †† Data on file. W. L. Gore & Associates, Inc; Flagstaff, AZ.
    ‡‡ Safety outcomes defined as a calculation of the proportion of subjects that experienced one or more SAEs within 30 days post-index procedure or a device event (embolization, device removal, reintervention after completion of index procedure) through 6 months, 12 months and 36 months post-index procedure.

    1. Qureshi AM, Sommer RJ, et al; GORE ASSURED Clinical Trial Investigators. Long-term results of the Atrial Septal Defect Occluder ASSURED Trial for combined pivotal/continued access cohorts. JACC: Cardiovascular Interventions. In press.
    2. O’Byrne ML, Glatz AC, Sunderji S, et al. Prevalence of deficient retro-aortic rim and its effects on outcomes in device closure of atrial septal defects. Pediatric Cardiology 2014;35(7):1181-11.
    3. GORE® CARDIOFORM ASD Occluder [Instructions for Use]. Flagstaff, AZ.: W. L. Gore & Associates, Inc; 2024. MD200690. 
    IFU Consult instructions

    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 THE U.S.: The GORE® CARDIOFORM ASD Occluder is a permanently implanted device indicated for the percutaneous, transcatheter closure of ostium secundum atrial septal defects (ASDs).  

    CONTRAINDICATIONS: The GORE® CARDIOFORM ASD 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 ASD 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.

    24CR1031-EN01