atHeart Medical, a medical device company focused on closure of atrial septal defects (ASD), announced that it has commenced operations. The company also advised it will initiate the ASCENT-ASD pivotal trial in the United States for its first product, the reSept ASD occluder.
atHeart Medical is led by CEO Laurent Grandidier and has offices in Baar, Switzerland and Mountain View, California. It is part of Olle Larsson Holding, a Swiss corporate group with a portfolio of medical device companies, including the engineering and consulting firm Carag AG. Carag initially developed the reSept ASD Occluder technology.
According to atHeart Medical, the reSept device features a metal-free, bioresorbable frame. It is designed to reduce the risk of complications associated with the long-term presence of metal in the heart and to preserve future treatment options requiring transseptal intervention.
ASCENT-ASD is an FDA-approved investigational device exemption trial that will evaluate the safety and efficacy of the reSept ASD occluder for treating patients with clinically significant, isolated ASD. The prospective, single-arm investigation will enroll up to 250 patients at multiple sites globally. Primary endpoints will be compared with established performance goals for previously FDA-approved transcatheter ASD occluders, stated the company.
Larry Latson, MD, who is Director of Pediatric Interventional Cardiology at the Joe DiMaggio Children’s Hospital in Hollywood, Florida, serves as coprincipal investigator of the ASCENT-ASD trial.
“Currently available occluders leave a significant amount of metal in the heart, which could cause issues later in life,” commented Dr. Latson in the company’s announcement, “The unique design of this bioresorbable frame is promising, especially for my younger patients. I look forward to this upcoming trial.”