The reSept ASD Occluder is the first occluder with a metal-free, bioresorbable frame. It is designed to overcome the limitations of current transcatheter occluders by reducing the risk of complications associated with the long-term presence of metal in the heart and to preserve future treatment options requiring transseptal intervention.
April 20, 2021 — Start-up medical device company atHeart Medical announced it is initiating its U.S. investigational device exemption (IDE) trial for its novel transcatheter reSept atrial septal defect (ASD) occluder.
The reSept ASD Occluder is the first structural heart occluder with a metal-free, bioresorbable frame. The novel implant is designed to overcome the limitations of current transcatheter occluders. It is hoped the design will 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. Initial clinical experience demonstrates long-term clinically effective closure of the ASDs treated with the company's device, the company said.
"I am excited to lead atHeart Medical and for the potential of our first product, the reSept ASD Occluder, for patients requiring ASD closure," said Laurent Grandidier, CEO of atHeart Medical. "With such an experienced team, we have hit the ground running and are focused on preparing initial clinical sites in our U.S. IDE pivotal trial."
The ASCENT-ASD pivotal trial is an FDA-approved IDE study 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.
"Currently available occluders leave a significant amount of metal in the heart, which could cause issues later in life," stated Larry Latson, M.D., co-principal investigator of the IDE trial and director of pediatric interventional cardiology at the Joe DiMaggio Children's Hospital in Hollywood, Fla. "The unique design of this bioresorbable frame is promising, especially for my younger patients. I look forward to this upcoming trial."
Commonly described as a "hole in the heart," an ASD is an opening in the septum between the left and right atria. Most ASDs are congenital defects, affecting six in 10,000 births. They can also be the result of a procedure that requires transseptal crossing. A large atrial septal defect can cause extra blood to overfill the lungs and overwork the right side of the heart. If not treated, the right side of the heart eventually enlarges and weakens. The blood pressure in the lungs can also increase, leading to pulmonary hypertension. When ASDs require closure, the standard of care is to have an occluder implanted through a minimally invasive procedure.
atHeart Medical is a medical device company with offices in Switzerland and the United States. atHeart Medical is part of the Olle Larsson Holding, a Swiss corporate group with a diverse portfolio of medical device companies, including the engineering and consulting firm CARAG, which initially developed the reSept ASD Occluder technology.
For more information: www.atheartmedical.com
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1. CDC Website. https://www.cdc.gov/ncbddd/heartdefects/atrialseptaldefect.html, accessed April 20, 2021.