9-ASD-004
SJM Amplatzer Septal Occluder 4mm
$320.00
box of 1
In Stock: 1 Each
Expiration:
Expired
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The item listed above is expired and may be used for educational, training, and non-clinical research purposes only. Any product information appearing below, including the product indication statement, pertains to an in-date item only.
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Description
Abbott SJM St. Jude Medical Amplatzer Septal Occluders for Closure of Atrial Septal Defects (ASD)
Minimally Invasive ASD Occluders
Amplatzer™ Septal Occluders are the standard of care for minimally invasive atrial septal defect (ASD) closure. These double-disc occluders are comprised of nitinol mesh and polyester material. They are designed to securely appose the septal wall on each side of the defect and create a platform for tissue in-growth after implantation.
Amplatzer Septal Occluder
The Amplatzer™ Septal Occluder has a wide waist that centers the device and fills the ASD for optimal occlusion. The transcatheter delivery makes it the proven standard of care for the occlusion of ASDs.
Indication for Use
The Amplatzer™ Septal Occluder is a percutaneous, transcatheter, atrial septal defect closure device intended for the occlusion of atrial septal defects (ASD) in secundum position or patients who have undergone a fenestrated Fontan procedure and who now require closure of the fenestration. Patients indicated for ASD closure have echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (such as, 1.5:1 degree of left-to-right shunt or RV enlargement).
Contraindications
The Amplatzer™ Septal Occluder is contraindicated for the following: Any patient known to have extensive congenital cardiac anomaly which can only be adequately repaired by way of cardiac surgery; Any patient known to have sepsis within 1 month prior to implantation, or any systemic infection that cannot be successfully treated prior to device placement; Any patient known to have a bleeding disorder, untreated ulcer, or any other contraindications to aspirin therapy, unless another antiplatelet agent can be administered for 6 months; Any patient known to have a demonstrated intracardiac thrombi on echocardiography (especially left atrial or left atrial appendage thrombi); Any patient whose size (such as, too small for transesophageal echocardiography probe, catheter size) or condition (active infection, etc.) would cause the patient to be a poor candidate for cardiac catheterization; Any patient where the margins of the defect are less than 5 mm to the coronary sinus, inferior vena cava rim, AV valves, or right upper lobe pulmonary vein.
Additional information
| Size | 4.00mm |
|---|---|
| Arms | N/A |
| Manufacturer | |
| Unit | box of 1 |
- FDA Product Code: MLV
- FDA Product Code Name: Transcatheter septal occluder
- GMDN Term Code: 45418
- GMDN Term Name: Cardiac defect occluder
- GMDN Term Description: 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.
