9-ASD-008: SJM Amplatzer Septal Occluder 8mm

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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.

Abbott St. Jude Medical has long been a leader in vascular care, through its stents and related products. And, in recent years, the company has built a strong position in mitral valve repair with its MitraClip device. The agreement to acquire St. Jude Medical broadens Abbott's presence in virtually every aspect of cardiovascular care, and will make Abbott one of the world leaders in the broad medical device market.