AtHeart Medical Begins Trial for Atrial Septal Defect Occluder

AtHeart Medical has begun an investigational device exemption trial for its reSept atrial septal defect (ASD) occluder.

The first occluder that features a metal-free bioresorbable frame, the device is designed to overcome the limitations of current occluders by reducing the risk of complications associated with the long-term presence of metal in the heart. AtHeart anticipates that the device will provide clinically effective closure of ASD, which is often described as a hole in the heart.

The pivotal trial will evaluate the device’s safety and efficacy in up to 250 patients at multiple sites around the world. The researchers will compare the study results against established performance goals for transcatheter ASD occluders previously cleared by the agency.