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.

Occlutech ASD Training Information:

The Occlutech ASD Occluder must be implanted exclusively by physicians trained in its use and are experienced with interventional transcatheter ASD closure techniques and are able to determine suitable patients for procedures using this device. Physicians who implant the Occlutech ASD Occluder must be able to recognize, assess and manage procedure associated emergencies. Although the device is designed to be used only by experienced users (physicians, professional health care personnel), physicians should participate in the physician training program for new customers to ensure that all implanting physicians are trained on the use of the Occlutech ASD Occluder. The Occlutech ASD Occluder shall only be implanted by an experienced and trained physician, and in a specialized catheterization laboratory.

A complete list of indications, contraindications, warnings, and precautions can be found in the Occlutech® ASD Occluder Brochure in the list of related documents.