HeartR ASD Occluder - Manual

The HeartR Atrial Septal Defect (ASD) Occluder is a percutaneous, transcatheter closure device for the non-surgical closure of ASD. The system includes the HeartRTM ASD Occluder and the SteerEaseTM Introducer. The HeartRTM ASD Occluders have two types, HeartRTM ASD Occluder and HeartRTM Multi-fenestrated (Cribriform) ASD Occluder as shown in Figure 1. The HeartRTM ASD Occluder is a self-expandable double disc device, which is made of a nitinol wire mesh that is shaped into two flat discs and a waist between the two discs to fit the defect size. PET membranes sewn into each disc and the waist (no PET membrane sewn into the waist for multifenestrated ASD occluder) help to seal the hole and provide a foundation for growth of tissue over the occluder after placement.