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US Device Guide / Septal Occluders

Company Name Product Name Recommended Size of Introducer (F) Recommended Diameter of Defect for Device (mm) Device Size (mm) Delivery Device Length (cm) US FDA Indicated Use Comments
Abbott Amplatzer Duct Occluder 5–7-F TorqVue Delivery Systems (device size determines delivery sheath selection) Ability to close ductus 3–12 mm in diameter; ≥ 5 mm in length 5/4, 6/4, 8/6, 10/8, 12/10 (device diameter at descending aorta/device diameter at pulmonary artery) 60 (5–7 F), 80 (6–7 F) Transcatheter occlusion of patent ductus arteriosus Nitinol and polyester construction allows its use on varied PDA shapes and size
Abbott Amplatzer Duct Occluder II 4–5-F TorqVue Low Profile Delivery Systems (device size determines delivery sheath selection) Ability to close ductus 2.5–5.5 mm in diameter; ≥ 5 mm in length 3–4, 3–6, 4–4, 4–6, 5–4, 5–6, 6–4, 6–6 (waist diameter–device length) 60, 80 Nonsurgical closure of patent ductus arteriosus Fabric-free technology allows for lower-profile device and delivery systems; three articulated lobes create six planes of occlusion
Abbott Amplatzer Multi-Fenestrated Septal Occluder - Cribriform 8–10-F TorqVue Delivery Systems (device size determines delivery sheath selection) Shortest distance from defect to aortic root or distance from defect to superior vena cava orifice: 18-mm device for distances between 9–12.4 mm, 25-mm device for distances 12.5 mm and 14.9 mm, 30-mm device for distances between 15–17.4 mm, and 35-mm device for distances ≥ 17.5 mm; do not implant if defect is < 9 mm 18, 25, 30, 35 60, 80 Transcatheter multifenestrated atrial septal defect closure Nitinol and polyester construction; thin waist offers optimal fit and occlusion of the multifenestrated atrial septal defect
Abbott Amplatzer Muscular VSD Occluder 6–9-F TorqVue Delivery Systems (device size determines delivery sheath selection) Ability to close 4–18-mm defects 4–18 (waist diameter VSD) 60 (6–8 F), 80 (6–9 F) Transcatheter muscular septal defect closure Nitinol and polyester fabric in the device waist and discs provide for rapid occlusion properties
Abbott Amplatzer PFO Occluder 8–9-F TorqVue Delivery Systems (device size determines delivery sheath) Device sizes available: 18–35 mm; size of the device based on PFO morphology while taking into consideration the distances from the PFO to the aortic root and SVC 18, 25, 35 60, 80 Transcatheter closure of patent foramen ovale Nitinol and polyester construction, recapturable and repositionable, self-centering
Abbott Amplatzer Septal Occluder 6–12-F TorqVue Delivery Systems (device size determines delivery sheath selection) Ability to close 4–38-mm defects; 40-mm device not available in the United States 4–38 (waist diameter ASD) 60, 80 Transcatheter atrial septal defect closure Low-profile, nitinol and polyester construction; device waist fills defect for optimal fit and occlusion; endothelialization process promotes low thrombogenicity; low risk of erosion
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
PFM Medical Inc. (distributed by B. Braun Interventional Systems Inc.) Nit-Occlud PDA 4–5-F delivery system (device size determines delivery system size) Ability to close ductus with minimum angiographic diameter < 4 mm 4 X 4, 5 X 4, 6 X 5, 7 X 6, 9 X 6, 11 X 6 (distal X proximal coil diameter) 85 Percutaneous, transcatheter closure of small to moderate size patent ductus arteriosus Designed to match individual morphologies and sizes; tight and compact windings ensure efficient occlusion; repositionable and retrievable prior to release; strong distal windings avoid "pull through"

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