Trusted closure performance at 6 months*,1,2
| Characteristics of complex ASDs | |
|---|---|
| ASD Category | Anatomical Characteristics |
| Complex |
|
No retro-aortic rim requirements2
Gore ASSURED Clinical Study:
of patients enrolled in the Gore ASSURED Clinical Study were reported to have deficient retro-aortic rims (< 5 mm)1
effective closure at 6 months*,1,2
GORE® CARDIOFORM ASD Occluder
No warnings, potential adverse events or precautions related to cardiac erosions or use in patients with deficient retro-aortic rims.†,1,2
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Case examples
Deficient retro-aortic rim < 5 mm
Image courtesy of Bryan Goldstein, M.D. Used with permission.
Image 1A. Transesophageal echocardiogram (TEE) showing interrogation of ASD with deficient retro-aortic rim.
Image courtesy of Bryan Goldstein, M.D. Used with permission.
Image 1B. Closure of ASD with a deficient retro-aortic rim with the GORE® CARDIOFORM ASD Occluder.
Large ASD with deficient posterior-inferior rim
Image courtesy of Alvaro Galindo, M.D. Used with permission.
Image 2A. TEE demonstrating large ASD with a deficient posterior-inferior rim.
Image courtesy of Alvaro Galindo, M.D. Used with permission.
Image 2B. Closure of ASD with a deficient posterior-inferior rim with a GORE® CARDIOFORM ASD Occluder.
Multiple defects with atrial septal aneurysm (ASA)
Image courtesy of Alvaro Galindo, M.D. Used with permission.
Image 3A. TEE demonstrating multiple ASDs with ASA.
Image courtesy of Alvaro Galindo, M.D. Used with permission.
Image 3B. Closure of multiple ASDs with ASA with a GORE® CARDIOFORM ASD Occluder.
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* Closure success defined as completely occluded or clinically insignificant shunt as determined by the Echo Core Lab at the 6-month evaluation among subjects with technical success.2
† Deficient retro-aortic rim was defined as a retro-aortic rim measuring less than or equal to 5 mm on any view on echocardiogram.
- Sommer RJ, Love BA, Paolillo JA, et al.; ASSURED Investigators. ASSURED clinical study: new GORE® CARDIOFORM ASD Occluder for transcatheter closure of atrial septal defect. Catheterization & Cardiovascular Interventions 2020;95(7):1285-1295.
- GORE® CARDIOFORM ASD Occluder [Instructions for Use]. Flagstaff, AZ.: W. L. Gore & Associates, Inc; 2024. MD200690.
- Hijazi ZM, Feldman T, Mustafa H, et al. Transcatheter Closure of ASDs and PFOs: A Comprehensive Assessment. 1st Edition. Cardiotext Publishing. 2010.
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
24CR2023-EN01