Over 25 patients have joined the ASCENT ASD study in the Midwest to date. They have received a reSept ASD occluder for their atrial septal defect (ASD) closure. This results from the joint effort of a significant group of hospitals enrolling patients in the study in this region.
Patients with an ASD that needs closing may contact one of the seven Midwestern centers, to learn if they may be able to participate in the ASCENT ASD study. The enrolling centers include Advocate Children’s Hospital (Oak Lawn, IL), Riley Hospital for Children (Indianapolis, IN), University of Michigan (Ann Arbour, MI), Children’s Hospital of Michigan (Detroit, MI), Washington University School of Medicine (Saint Louis, MO), Cincinnati Children’s Hospital (Cincinnati, OH) and Nationwide Children’s Hospital (Columbus, OH). Contact details of the enrolling centers are available here.
“On Thanksgiving week, we are grateful to the incessant work of the clinicians and study coordinators participating in the ASCENT ASD study,” said atHeart Medical CEO, Laurent Grandidier. “They are enabling patients that need ASD closure in the Midwest and in all US regions to access a new, technological evolution for their treatment.”
reSept ASD Occluder
Unlike existing ASD devices, the reSept ASD Occluder has a metal-free frame. Its structure includes two fabric disks connected by resorbable synthetic filaments. As the filaments hold the disks closely together, tissue covers and embeds the disks in the repaired septum. When no longer needed, the filaments dissolve in the body. They turn into water and CO2 to be expelled and exhaled within two years.
Today, reSept has been implanted in over 100 patients. The first procedures date back more than 10 years.
The ASCENT ASD study
The ASCENT ASD study is assessing how safe and effective the reSept ASD Occluder is for closing atrial septal defects. reSept is the first ASD occluder with a metal-free, resorbable frame.
“We are partnering with enrolling centers in many different areas to help reduce the logistical barriers for families of patients that decide to participate in the study,” said Brandi Sadowski, atHeart Medical’s Vice President for Clinical Affairs and Regulatory. “We are grateful to the patients that have come forward to join this innovative effort for ASD treatment across the USA and Europe so far.”
An atrial septal defect is a hole in the wall between the two top chambers of the heart. ASDs are among the most common heart defects in children. Most patients can be treated with an ASD occluder through a minimally invasive procedure. However, currently available occluders have a metal frame that stays in a patient’s heart for life.