Innovative Implantable Occluder Treats Isolated ASDs
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By HospiMedica International staff writers Posted on 27 Jul 2021 |
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Image: The reSept ASD Occluder (Photo courtesy of atHeart Medical)
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.
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.
Related Links:
atHeart Medical
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.
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.
Related Links:
atHeart Medical
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