Joe DMaggio Heart Surgeons participate in pivotal ASD treatment trial
July 04, 2022
On behalf of our pediatric cardiac team, I’m excited to announce successful treatment of a patient with atrial septal defects (ASD), using the first transcatheter ASD occluder with a metal-free frame. We implanted the novel device, as part of the ASCENT ASD U.S. Investigational Device Exemption (IDE) pivotal trial, which will evaluate the safety and efficacy of the transcatheter reSept ASD Occluder in patients with clinically significant secundum ASDs.
What’s An ASD?
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.1 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.
Metal-Free: Fewer complications, transseptal intervention limits
When ASDs require closure, the current standard of care is to implant a septal occluder with a metallic frame through a minimally invasive procedure. ASD occluder metallic frames could place patients at risk for complications associated with long-term presence of metal in the heart and may limit future transseptal interventions.
The reSept ASD Occluder is the first transcatheter ASD occluder with a metal-free frame. It is an investigational medical device manufactured by atHeart Medical. “The metal-free frame of the reSept ASD Occluder provides a low-profile that over time is replaced by the patient’s tissue, leaving a minimal implant behind and restoring a more natural septum when compared to current occluder devices,” stated Saibal Kar, MD, Interventional Cardiology at the Los Robles Regional Medical Center in Thousand Oaks, California and Co-Principal Investigator of the IDE trial. “This provides a unique opportunity for physicians to effectively address ASDs while being mindful of any patient’s potential transseptal procedures later in life.”
Initial clinical experience demonstrates effective closure of the ASDs treated with the novel investigational device.2 The prospective, single-arm study 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.
Our first ASD trial patient
This represents our hospital’s first patient with ASD enrolled in this worldwide trial. With studies of this kind and world-wide collaboration, we can give our patients access to the most innovative treatments that will transform the way we treat congenital heart disease in the future.
Rewarding Collaborations
“It is incredibly exciting to have the participation of Joe DiMaggio Children’s Hospital to this important pivotal trial,” said Laurent Grandidier, CEO of atHeart Medical. “I commend the team’s diligence to expanding the body of evidence supporting our reSept ASD Occluder and dedication to delivering innovation to patients with ASDs around the world.”
1 https://www.cdc.gov/ncbddd/heartdefects/atrialseptaldefect.html
2 Sievert K, et al. Transcatheter closure of atrial septal defect and patent foramen ovale with Carag bioresorbable septal occluder: first-in-man experience with 24-month follow-up. EuroIntervention. 2021 Nov 1:EIJ-D-21-00740. doi: 10.4244/EIJ-D-21-00740. Epub ahead of print. PMID: 34726601.