| Gore & Associates |
Gore Cardioform ASD Occluder
|
10 (27-mm max outer disc diameter); 10 (32-mm max outer disc diameter); 11 (37-mm max outer disc diameter); 12 (44-mm max outer disc diameter); 14 (48-mm max outer disc diameter)* |
27 max outer disc diameter (recommended treatable defect size measured with stop flow balloon sizing, 8-15); 32 max outer disc diameter (recommended treatable defect size measured with stop flow ballon sizing, 13-20); 37 max outer disc diameter (recommended treatable defect size measured with stop flow balloon sizing, 18-25); 44 max outer disc diameter (recommended treatable defect size measured with stop flow balloon sizing, 23-30); 48 max outer disc diameter (recommended treatable defect size measured with stop flow balloon sizing, 28-35) |
27, 32, 37, 44, 48 |
Working length of delivery system is 80 cm for GCA; if a 0.035-inch guidewire is used, increasing the introducers sheath by 2 F is recommended |
A permanently implanted device indicated for the percutaneous transcatheter closure of ostium secundum atrial septal defects |
*If a 0.035-inch guidewire is used, increasing the introducer sheath by 2 F is recommended |
| Gore & Associates |
Gore Cardioform Septal Occluder
|
Without a guidewire: ≥ 10; with a guidewire: ≥ 12 |
Nominal device diameter ranging from 20–30 mm, should be at least 1.75 times that of the defect diameter |
20, 25, 30 |
75 |
A permanently implanted device indicated for the percutaneous, transcatheter closure of the following defects of the atrial septum: (1) ostium secundum atrial septal defects and (2) patent foramen ovale to reduce the risk of recurrent ischemic stroke in patients, predominantly between ages 18 and 60 years, who have had a cryptogenic stroke due to a presumed paradoxical embolism, as determined by a neurologist and cardiologist following an evaluation to exclude known causes of ischemic stroke |
Minimal wire nitinol frame; thromboresistant ePTFE membrane allows tissue ingrowth; soft, conformable design to reduce wall injury; fully retrievable even after tension-free assessment |