A leader in safety
No reported cases of cardiac erosion for GORE® CARDIOFORM ASD Occluder*,1
| Cardiac erosions reported for ABBOTT® AMPLATZER Occluders:5,6 | |||
|---|---|---|---|
ABBOTT® AMPLATZER® Reported between 2002 and 20145 | 125 Erosions5 | 9 Deaths5 | 7.2% Mortality rate for patients with reported erosions5 |
ABBOTT® AMPLATZER® Reported between 2012 and 20186 | 90 Erosions6 | 4 Deaths6 | 4.4% Mortality rate for patients with reported erosions6 |
Wire frame fracture analysis
No reported cases of clinical sequelae associated with device wire frame fracture†,1
| Summary of reported incidence of clinical sequelae associated with device wire frame fractures for the GORE® CARDIOFORM ASD Occluder†,1 | ||||
|---|---|---|---|---|
| Occluder | First use in humans | Approval year (EU and U.S.) | Devices sold globally | Reported incidence of clinical sequelae associated with device wire frame fracture at six months |
| GORE® CARDIOFORM ASD Occluder | 2015 | 2019 | > 8,000 | 0 |
| GORE® CARDIOFORM ASD Occluder Pivotal IDE Study for ASD closure: summary of wire frame fracture occurrence at six-month follow-up.1,7 | ||||||
|---|---|---|---|---|---|---|
| All enrolled subjects (N = 125) | Overall | 27 mm | 32 mm | 37 mm | 44 mm | 48 mm |
| Fluoroscopy completed at six months | 104 | 19 | 38 | 23 | 19 | 5 |
| Wire frame fracture at six months | 37 (35.6%) | 5 (26.3%) | 9 (23.7%) | 8 (34.8%) | 12 (63.2%) | 3 (60.0%) |
| Clinical sequelae at six months associated with device wire frame fracture | 0 | 0 | 0 | 0 | 0 | 0 |
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* Reported incidence rate of device-related cardiac erosions for GORE® CARDIOFORM ASD Occluder calculated using data from CATSWeb® Product Surveillance Tracking System [PSTS] and Smartsolve.® Data on file. March 1, 2015 – May 31, 2023; W. L. Gore & Associates Inc.; Flagstaff, AZ.
† Reported incidence rate of clinical sequelae associated with wire frame fracture for GORE® CARDIOFORM ASD Occluder. Calculated using data from CATSWeb® Product Surveillance Tracking System [PSTS] and SmartSolve.® Data on file. March 1, 2015 – May 31, 2023. W. L. Gore & Associates, Inc.; Flagstaff, AZ.
1. 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.
2. AMPLATZER™ Septal Occluder [Instructions for Use]. Plymouth, MN: Abbott Medical; 2022. ARTEN600196097 B.
3. Crawford GB, Brindis RG, Krucoff MW, Mansalis BP, Carroll JD. Percutaneous atrial septal occluder devices and cardiac erosion: a review of the literature. Catheterization & Cardiovascular Interventions 2012;80(2):157-167.
4. Turner DR, Owada CY, Sang CJ Jr, Khan M, Lim DS. Closure of secundum atrial septal defects with the AMPLATZER Septal Occluder: a prospective, multicenter, post-approval study. Circulation: Cardiovascular Interventions 2017;10(8):e004212.
5. McElhinney DB, Quartermain MD, Kenny D, Alboliras E, Amin Z. Relative risk factors for cardiac erosion following transcatheter closure of atrial septal defects: a case-control study. Circulation 2016;133(18):1738-1746.
6. Bier ML, Dhawan P, Shah SU, et al. Cardiac erosions with the Amplatzer Septal Occluder: adverse events in the Manufacturer and User Facility Device Experience (MAUDE) Database since the 2012 FDA review. Structural Heart. 2021;5(1):85-89.
7. GORE® CARDIOFORM ASD Occluder [Instructions for Use]. Flagstaff, AZ.: W. L. Gore & Associates, Inc; 2023. MD190349.
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.
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
ABBOTT is a trademark of Abbott Laboratories.
AMPLATZER is a trademark of St. Jude Medical.
CATSWeb is a trademark of AssurX, Inc.
SMARTSOLVE is a trademark of Ethos Technologies Inc.
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