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Septal Occluders
11 products
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| Compare | 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 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 | |
| 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" | |
| B. Braun Interventional Systems/Vena Tech | Occlutech ASD Occluder | 7–12 | 5–33 | 6–33 | 79 | Indicated for (1) echocardiographic evidence of ostium secundum-type atrial septal defects; (2) clinical evidence of right ventricular (RV) volume overload (hemodynamically significant left-to-right shunt with Qp/Qs ≥ 1.5 or RV enlargement); see the Instructions for Use for full prescribing information including warnings, precautions and contraindications at www.bisusa.com | Intended for percutaneous transcatheter closure of ostium secundum-type atrial septal defects; self-centering occluder containing double discs and waist and is designed without left atrial hub; combined flexible wires produce a conformable device to facilitate a natural deployment position | |
| B. Braun Interventional Systems, Inc. | Occlutech ASD Occluder | 6-12 | 5-33 | waist size 6-33 | 120 | Intended for transcatheter closure of ostium secundum-type atrial septal defects | - |
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