atHeart Medical Receives FDA Approval for the Second Phase of the ASCENT ASD U.S. IDE Trial
Company’s reSept™ ASD Occluder Aims to Evolve Septal Closure with its Novel Metal-Free Frame Design
Excerpt from the Press Release:
BAAR, Switzerland and SANTA CLARA, Calif., Feb. 8, 2022 /PRNewswire/ — atHeart Medical, a medical device company dedicated to establishing the new standard of care for closure of atrial septal defects (ASD), today announced it has received approval for the start of the second phase of its ASCENT ASD U.S. Investigational Device Exemption (IDE) pivotal trial.
The prospective, single-arm study is evaluating the safety and efficacy of the reSept™ ASD Occluder, the first occluder with a metal-free, bioresorbable frame, for the treatment of patients with clinically significant, isolated ASDs. Primary endpoints will be compared with established performance goals for previously FDA-approved transcatheter ASD occluders.
“I am pleased the first phase of enrollment in our pivotal trial progressed smoothly and according to plan, this is an exciting milestone for the company,” said Laurent Grandidier, CEO of atHeart Medical. “As we initiate the second phase, our team is focused on adding clinical sites across the U.S. and expanding internationally to include several enrolling sites in France. I commend the team’s diligence to further validating the safety and efficacy of the reSept ASD Occluder, a critical step in our journey to evolve septal closure and provide a better solution for patients.”
The reSept ASD Occluder aims to address the limitations of current occluders which have 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 demonstrates positive safety and performance in the closure of the ASDs treated with the company’s device.1
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