atHeart Medical’s reSept ASD Occluder Studied in ASCENT ASD United States Pivotal Trial

July 14, 2021—atHeart Medical announced the enrollment of the first five patients in ASCENT ASD, a United States investigational device exemption pivotal trial. This is the first study in the United States for the company, which is developing a closure device for atrial septal defects (ASDs). atHeart Medical has offices in Baar, Switzerland, and Mountain View, California.

According to atHeart Medical, the ASCENT ASD clinical investigation aims to demonstrate the safety and efficacy of the company’s reSept ASD occluder for treating clinically significant secundum ASD with a transcatheter approach as compared to predefined performance goals from other commercially available occluder devices. The prospective, single-arm, global, multicenter trial will enroll up to 250 patients.

Saibal Kar, MD, interventional cardiologist at the Los Robles Regional Medical Center in Thousand Oaks, California, and Coprincipal Investigator of the trial, commented in the company’s announcement, “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. This provides a unique opportunity for physicians to effectively address ASDs while being mindful of our patient’s potential need for subsequent transseptal procedures.”

The initial patients in the trial were treated by Thomas Jones, MD, Cardiac Catheterization Laboratory Director at Seattle Children’s Hospital in Seattle, Washington; Scott Lim, MD, Medical Director of the Advanced Cardiac Valve Center at the University of Virginia in Charlottesville, Virginia; and Thomas Forbes, MD, Director of Cardiac Catheterization Laboratory at Children’s Hospital of Michigan in Detroit, Michigan.

In the press release, Dr. Jones stated, “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. We look forward to continuing enrollment and further validation of this promising technology.”