Circulatory System Devices Panel of the Medical Devices Advisory Committee

Circulatory System Devices Panel of the Medical Devices Advisory Committee
Committee Meeting May 24, 2012 8:00 a.m. - 6:00 p.m

Agenda: On May 24, 2012, the committee will discuss current knowledge about the safety and effectiveness of the AMPLATZER ASO Device & Gore HELEX ASD Occluder as transcatheter Atrial Septal Defect (ASD) occluders used for the closure of secundum atrial septal defects. The AMPLATZER Septal Occluder (ASO) Device was the first device introduced to the US market in 2001 followed by the Gore HELEX device in 2006. With more widespread use of these devices, more information has become available regarding adverse events. These events range from rare life-threatening events to more common events that are perceived to have less severe clinical sequelae. Many of these events were evident in the premarket studies; however, rare events such as erosion were not seen. The purpose of discussion of these events is: (1) to discuss the significance of these events in the overall context of the disease and existing treatment options; (2) to discuss whether additional measures should be taken to improve protection of the public health (e.g., additional study and/or data analyses, labeling changes); and (3) to communicate to patients and physicians what is and is not known about device treatment options.