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Swissmedic approved the ASCENT ASD trial of reSept ASD Occluder in Switzerland. Following the authorization from the Swiss health authorities, the research study will soon begin to enroll patients with atrial septal defects (ASDs) in selected hospitals in the country.

“With our European headquarter in Switzerland, it is particularly important for us to receive the green light for our research by the Swiss authorities,” said atHeart Medical CEO Laurent Grandidier. “We work to improve the standard of care in atrial septal closure, and we are pleased to be able to do it in our closest community.”

In addition to Switzerland, the trial has recently received approval in Canada, and has enrolled over 80 patients so far in France and in the United States across more than 20 sites.

ASCENT ASD is a prospective, single-arm study evaluating the safety and efficacy of reSept ASD Occluder, the first occluder with a metal-free, bioresorbable frame, to treat patients with clinically significant, isolated ASDs. Primary endpoints will be compared with established performance goals of transcatheter ASD occluders currently available.

Please find further information on ASDs here.