Occlutech^® ASD Occluder

The Occlutech^® ASD Occluder is intended for percutaneous transcatheter closure of ostium secundum-type atrial septal defects (ASD). It is a self-centering occluder containing double discs and wide waist and is designed without a left atrial hub. The flexible wires produce a conformable¹ device to facilitate a natural deployment position.²

Indications:

The Occlutech ASD Occluder is a medical device intended for transcatheter closure of ostium secundum-type atrial septal defects (ASD). Patients indicated for ASD closure have:

• echocardiographic evidence of ostium secundum-type ASD,
• clinical evidence of right ventricular (RV) volume overload (hemodynamically significant left-to-right shunt with Qp / Qs ≥ 1.5 or RV enlargement).

Contraindications: 

The Occlutech ASD 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 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.