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Occlutech International AB
La Cours gata 4, 252 31, Helsingborg, Sweden
PHONE: +46 70433 65 21
Structural Heart / Septal Occluders
View Chart| 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 |
|---|---|---|---|---|---|---|---|
| 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 |
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Other Devices / Closure Devices
View Chart| Company Name | Product Name | Type | Puncture Size (F) | Maximum Wire Compatibility (inch) | CE Mark Indications | Comments |
|---|---|---|---|---|---|---|
| Occlutech International AB | Occlutech Hubless PDA Occluder | Patent ductus arteriosus closure device | No puncture needed | 0.038 | Yes | Percutaneously implanted through a catheter intervention technique and intended for the nonsurgical occlusion of patent ductus arteriosus |
Structural Heart / Atrial Shunts
View Chart| Company Name | Product Name | Device Size/Shunt Diameter (mm) | Outer Diameter (mm) | LA Profile (mm) | RA Profile (mm) | Delivery Type | Delivery System Working Length (cm) | Sheath Size (F) | Requires Predilation (Yes/No) | Device Design/Material | CE Mark Indication | Comments |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Occlutech International AB | Occlutech Atiral Flow Regulator (AFR) | Devices are available with 8- and 10-mm fenestration and 5- and 10-mm height options (4 sizes in total) | 21- and 23-mm for 8- and 10-mm devices, respectively | No protrusion in LA | No protrusion in RA | Transcatheter delivery | 80 | 12 F and 14 F for 8- and 10-mm, respectively | Yes | Nitinol wire mesh consists of a flexible waist that connects two retention discs, with a central fenestration | Indicated for use in patients with heart failure, irrespective of ejection fraction (for both HFrEF and HFpEF patients) | – |
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