atHeart Medical 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.”