atHeart Medical announced today the successful treatment of the first five patients in its ASCENT ASD U.S. Investigational Device Exemption (IDE) pivotal trial. This study, the company’s first in the US, will evaluate the safety and efficacy of the reSept ASD Occluder.
The initial patients were treated by Dr. Thomas Jones, Cardiac Catheterization Laboratory Director at Seattle Children’s Hospital (Seattle, WA), Dr. Scott Lim, Medical Director of the Advanced Cardiac Valve Center at the University of Virginia (Charlottesville, VA) and Dr. Thomas Forbes, Director of Cardiac Catheterization Laboratory at Children’s Hospital of Michigan (Detroit, MI). 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.
“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 Dr. Jones. “We look forward to continuing enrollment and further validation of this promising technology.”