atHeart Medical has announced the successful treatment of the first five patients in its ASCENT ASD US Investigational Device Exemption (IDE) pivotal trial. This study, the company’s first in the USA, will evaluate the safety and efficacy of the reSept atrial septal defect (ASD) occluder.
The initial patients were treated by Thomas Jones, cardiac catheterization laboratory director at Seattle Children’s Hospital (Seattle, USA), Scott Lim, medical director of the Advanced Cardiac Valve Center at the University of Virginia (Charlottesville, USA) and Thomas Forbes, director of Cardiac Catheterization Laboratory at Children’s Hospital of Michigan (Detroit, USA). The prospective, single-arm study will enrol up to 250 patients at multiple sites globally. Primary endpoints will be compared with established performance goals for previously US Food and Drug Administration (FDA)-approved transcatheter ASD occluders.
“I am pleased to be a part of this study and advance therapy options for septal defects that leave a minimal footprint behind. The reSept ASD occluder implanted easily and had a successful outcome with no residual shunts,” commented Jones. “We look forward to continuing enrolment and further validation of this promising technology.”
Current ASD occluders have metallic frames that can place patients at risk for complications and prohibit future transseptal interventions. Initial clinical experience demonstrates effective closure of the ASDs treated with the company’s device.
“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,” stated Saibal Kar, Los Robles Regional Medical Center in Thousand Oaks, USA and 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.”
“I am pleased to have such a strong start to this important pivotal trial and it is incredibly exciting to have the participation of so many leading institutions,” said Laurent Grandidier, CEO of atHeart Medical. “I commend the team’s diligence to expanding the body of evidence supporting our reSept device and dedication to delivering this lifesaving innovation to patients around the world.”