The Occlutech Atrial Septal Defect (ASD) Occluder is a percutaneous transcatheter closure device, consisting of 2 nitinol wire mesh discs connected by a waist section and polyethylene terephthalate (PET) patches. The PET patches, sewn into the wire mesh, are intended to stop the blood flow through the ASD as well as optimize tissue growth. The design properties of the Occlutech ASD Occluder allow transcatheter implant of the device. The Occlutech ASD Occluder (04260182521540) is packaged with its compatible Occlutech Pistol Pusher (OPP) (8683463400161), Instructions for Use (IFU) and Patient Implant Card.
An implantable disk-like device intended to be used for the minimally-invasive closure of cardiac defects and deployed using a dedicated delivery catheter/sheath. It is made of wire mesh [e.g., nickel-titanium alloy (Nitinol)], and possibly additional materials (e.g., polyester), and is typically self-expandable. The device is used to treat cardiac disorders that may include (but not limited to) atrial septal defect (ASD), ventricular septal defect (VSD), patent foramen ovale (PFO), or patent ductus arteriosus (PDA). Disposable devices dedicated to implantation may be included with the implant.
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