Advertisement

EUROPEAN 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) CE Mark Indications 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) 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 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 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) 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, 30,* 35; *30-mm device not available in United States 60, 80 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 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 atrial septal defects, such as ostium secundum and patent foramen ovale Minimal wire nitinol frame; thromboresistant ePTFE membrane allows tissue ingrowth; soft, conformable design to reduce wall injury; fully retrievable even after tension-free assessment
Invamed ICT Paravalvular Leak Closure Device 7 4–20 4–20 80–100 Paravalvular leaks in mechanical heart valves and deep venous valves (indicated for both coronary and peripheral use) Low-profile, hard gel closure occluder; device fills defect for optimal fit and occlusion; endothelialization process promotes low thrombogenicity
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 A proximal coil diameter) 85 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"
Occlutech International AB Occlutech ASD Occluder 7–12 Occlutech Delivery Systems (device size determines delivery sheath selection) 4–40 4, 5, 6, 7.5, 9, 10.5, 12, 13.5, 15, 16.5, 18, 19.5, 21, 24, 27, 30, 33, 36, 39, 40 (waist diameter) 80 Indicated for closure of an ASD II and is deployed via a minimally invasive catheter delivery system; intended for patients with substantiated left-right-shunt and a clear indication for closure of the defect Unique proprietary braiding technology allows for the creation of a device that has no LA clamp, avoiding any protruding hub into the left atrium
Occlutech International AB Occlutech mVSD Occluder 6–11 Occlutech Delivery Systems (device size determines delivery sheath selection) 4–20 (diameter); ≤ 7 (length) 4, 6, 8, 10, 12, 14, 16, 18, 20 (waist diameter) 80 A percutaneous, transcatheter muscular ventricular septal defect closure device designed for the occlusion of hemodynamically significant muscular ventricular septal defects Design of the device allows a smooth alignment over the defect and therefore the ability to achieve complete closure; once placed, the device exerts minimal pressure on the surrounding tissue
Occlutech International AB Occlutech PDA Occluder 6–9 Occlutech Delivery Systems (device size determines delivery sheath selection) 3.5–14 (diameter); ≥ 4.25 (length) 3.5/5, 4/6, 5/7, 6/8, 8/10, 10/12, 12/15, 14/18 (device diameter at descending aorta/device diameter at pulmonary artery) 80 Percutaneously implanted through a catheter intervention technique and intended for the nonsurgical occlusion of a patent ductus arteriosus Unique proprietary braiding technology allows for the creation of a device that has no distal clamp, avoiding any protruding hub from the aortic disc
Occlutech International AB Occlutech PFO Occluder 7–11 Occlutech Delivery Systems (device size determines delivery sheath selection) 8–18 16/18, 23/25, 27/30, 31/35 (diameter LA/RA disc) 80 Consists of a nitinol-wire mesh with “shape-memory” properties; a flexible waist connects the two small discs and conforms completely on the atrial septum once deployed; two very thin patches made of PET ensure faster sealing of the defect in the atrial septum while optimizing ingrowth of tissue Unique proprietary braiding technology allows for the creation of a device that has no LA clamp, avoiding any protruding hub into the left atrium
Occlutech International AB Occlutech PLD 6–10 Occlutech Delivery Systems (device size determines delivery sheath selection) 4 X 2–18 X 10 (crescentric-like); 3–7 (round) 4, 5, 6, 7 (square devices); 4 X 2, 6 X 3, 8 X 4, 10 X 4, 12 X 5, 14 X 6, 16 X 8, 18 X 10 (rectangular devices) 80, 110 Indicated for patients with PVL associated hemolysis, recurrent blood transfusions, or hemodynamically significant heart failure and who are deemed at high risk for surgical intervention after consultation with surgical physicians or as an alternative to surgery with less operational time and recovery period The first and only CE marked device for PVL closure with different shape and waist options
Occlutech International AB Occlutech PmVSD Occluder 6–7 Occlutech Delivery Systems (device size determines delivery sheath selection) 4–12 (diameter); ≤ 5 (length) 4, 6, 8, 10, 12 (waist diameter) 80 A percutaneous, transcatheter perimembraneous ventricular septal defect closure device designed for the occlusion of hemodynamically significant perimembraneous ventricular septal defects which are located in the membranous ventricular septum Unique braiding allows for postdeployment and self adjustment of the wire braid, minimizing tissue stress and pressure
Occlutech International AB Occlutech UNI Occluder for Multifenestrated ASDs 7–12 Occlutech Delivery Systems (device size determines delivery sheath selection) 8.4–19.5 17/17, 24/24, 28.5/28.5, 33/33, 40/40 (diameter LA/RA disc) 80 An implant used to close fenestrated (multifenestrated) atrial septal defects (ie, several smaller defects which a conventional Figulla Flex II ASD/Figulla Flex II PFO would not be able to completely close); closure of an atrial septal defect is indicated in the presence of clinical symptoms (dyspnoea and cardiac insufficiency) and where a significant left-right shunt exists (Qp:Qs, ≥ 1.5) Unique proprietary braiding technology, allows for the creation of a device that has no LA clamp, avoiding any protruding hub into the left atrium

Advertisement