atHeart’s reSept ASD Occluder to Be Evaluated in FDA-Approved ASCENT ASD Trial

February 8, 2022—atHeart Medical announced it has received approval for the start of the second phase of its ASCENT ASD United States investigational device exemption pivotal trial. atHeart is a medical device company based in Switzerland and the United States that is focused on closure of atrial septal defects (ASDs).

The prospective, single-arm ASCENT-ASD study aims to demonstrate the safety and efficacy of the reSept ASD occluder for treating clinically significant secundum ASD with a transcatheter approach as compared to predefined performance goals from other commercially available occluder devices. The global multicenter clinical investigation study will enroll a total of up to 250 patients.

The reSept device features a metal-free, bioresorbable frame.

The company stated that reSept ASD occluder aims to address the limitations of occluders with metallic frames that can place patients at risk of complications associated with long-term presence of metal in the heart and may limit future transseptal interventions, such as mitral valve interventions. Initial clinical experience has demonstrated positive safety and performance in the closure of the ASDs treated with reSept, noted the company.

“The low-profile reSept occluder is a dynamic system that allows for versatile physician control during the intervention, potentially adapting to the different patient anatomies to address ASDs,” commented Scott Lim, MD, in the company’s press release. “Over time, reSept’s metal-free frame resorbs, leaving a minimal implant behind. This is an exciting advancement that provides the potential to preserve future treatment options and potentially do better for our patients.”

Dr. Lim is Professor of Medicine & Pediatrics at the University of Virginia in Charlottesville, Virginia, which is a leading enrolling site in the trial.