Occlutech® ASD Occluder

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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.

References:

1) Pedra CAC, Pedra SF, Costa RN, et al. Mid-Term Outcomes after Percutaneous Closure of the Secundum Atrial Septal Defect with the Figulla-Occlutech Device. Journal of Interventional Cardiology. 2016;29(2):208-215. doi:https://doi.org/10.1111/joic.12284

2) Kenny D, Eicken A, Dähnert I, et al. A randomized, controlled, multi‐center trial of the efficacy and safety of the Occlutech Figulla Flex‐II Occluder compared to the Amplatzer Septal Occluder for transcatheter closure of secundum atrial septal defects. Catheterization and Cardiovascular Interventions. 2018;93(2):316-321. doi:https://doi.org/10.1002/ccd.27899