eClinical Technology and Industy News

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

Click the button below to read the entire Press Release:

Continue Reading The Press Release

Discover What Sets TrialStat Apart From Ordinary EDC Platforms

Click the image or button below to explore our eClinical Suite Platform and discover what sets TrialStat apart from competing EDC platforms.

Request Your Demo Today!

From rapid database build through database lock, we deliver consistent quality on-time and on-budget. Ready to upgrade your eClinical toolkit?

Archives