Innovative Implantable Occluder Treats Isolated ASDs

By HospiMedica International staff writers
Posted on 27 Jul 2021
A new atrial septal defect (ASD) occluder aims to establish a new standard of care for structural heart treatments.

The atHeart Medical (Baar, Switzerland) reSept ASD Occluder is a low-profile, metal-free, bioresorbable implant designed to reduce the risk of complications associated with long-term presence of metal in the heart. The occluder is made of bioresorbable filaments connecting two polyester fabric patches, which contain radiopaque markers. Delivered through a 12F sheath and over a standard guidewire, the device is fully deployed with the guidewire in place, providing the opportunity to reattach and reposition when necessary.

Image: The reSept ASD Occluder (Photo courtesy of atHeart Medical)

After endothelialization, the filaments slowly resorb, with complete resorption demonstrated in-vitro at 24 months. In addition, reSept has been designed to preserve future treatment options requiring surgery; the polyester fabric and the radiopaque markers remain, which may be useful for future transseptal procedure planning. Available in three sizes, the reSept ASD Occluder supports closure of defects of 4-22mm. The device is currently undergoing a prospective global multi-site clinical investigational device exemption (IDE) trial that will enroll up to 250 patients.

“The metal-free frame of the reSept ASD Occluder provides a low-profile that over time is replaced by the patient's tissue, leaving minimal implant behind and restoring a more natural septum when compared to current occluder devices,” said interventional cardiologist Saibal Kar, MD, of Los Robles Regional Medical Center (Thousand Oaks, CA, USA), co-principal investigator of the IDE trial. “This provides a unique opportunity for physicians to effectively address ASDs while being mindful of our patient's potential need for subsequent transseptal procedures.”

An ASD is a congenital defect resulting from an abnormal formation of the septum that divides the upper chamber into a left and right atrium. This can result in blood flow between the two upper heart chambers through the ASD, forming a shunt. As a result, pressure in the lungs may build up, causing less oxygen in the blood. Symptoms can include difficulty breathing, frequent respiratory infections in children, palpitation, and shortness of breath with activity.

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