The ASCENT ASD pivotal trial of atHeart Medical’s reSept ASD occluder has advanced to Stage 3 enrollment, following regulatory authorization of trial expansion by the US Food and Drug Administration (FDA) and by the French National Agency for Medicines and Health Products Safety (ANSM).
The positive decisions of the regulatory authorities followed the review of data from the first 50 US and EU patients, as part of the initial stages of this ongoing trial.
“Our team is delighted to progress with patient enrollment following the green light from the FDA and ANSM. We are committed to demonstrate that ASDs may be effectively closed without jeopardizing cardiovascular treatments that patients may need in the future,” said CEO Laurent Grandidier.
ASCENT ASD is a prospective, single-arm study 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. The trial is aiming to enroll a total of up to 250 patients.
View which US and EU hospital sites are actively recruiting patients in the ASCENT ASD trial here