atHeart Medical’s reSept ASD Occluder Evaluated in FIH and Pivotal Studies

June 25, 2024—atHeart Medical, a medical device company focused on atrial septal defects (ASD) closure that is based in Baar, Switzerland, and Santa Clara, California, recently announced long- and short-term clinical outcomes for its reSept ASD occluder.

According to atHeart Medical, the safety and efficacy findings from three patient cohorts contribute to a body of evidence for the device’s potential. The data were presented at the CSI Frankfurt conference held in Frankfurt, Germany on June 19-22, 2024.

The transcatheter reSept ASD occluder features a bioresorbable metal-free frame that is designed to enable future transseptal treatment. The frame is composed of two synthetic fabric patches connected by bioresorbable filaments that resorb in the body over time. The investigational device aims to address limitations of occluders with metallic frames that stay in a patient’s heart for life and can limit transseptal interventions, stated the company.

atHeart Medical outlined the reSept data presentations at CSI Frankfurt as follows:

• 10-year outcomes from the first-in-human (FIH) trial showing long-term efficacy and safety of the device were presented by Kolja Sievert, MD, from the CardioVascular Center Frankfurt in Frankfurt, Germany.
• 2-year data showing complete closure in a case study from the University of Virginia cohort of the ongoing ASCENT ASD pivotal trial were discussed by Scott Lim, MD, who is Professor of Medicine and Pediatrics at the University of Virginia School of Medicine in Charlottesville, Virginia. ASCENT ASD trial is approved in the United States, Canada, France, and Switzerland.
• 1-month efficacy of reSept in patients with iatrogenic ASDs (iASDs) caused by mitral valve intervention was demonstrated in the Canadian first-ever experience, which was presented by Fady Zaky, MD, from St Paul’s Hospital in Vancouver, Canada. The patient treatment was conducted through Health Canada’s Medical Devices Special Access Program.

Saibal Kar, MD, who is National Physician Director for HCA Healthcare in Los Angeles, California, serves as Coprincipal Investigator of the ASCENT ASD trial.

“Having pioneered reSept in its early days as part of ASCENT ASD in the United States, I am very pleased about the long-term outcomes from the earlier European FIH trial and the wealth of promising new data available,” commented Dr. Kar in the atHeart Medical press release. “They indicate how transcatheter ASD closure with a bioresorbable device could become an even less invasive procedure for patients long-term. This is a very exciting development for our patients.”

The company noted that approximately 100 patients with ASDs have been successfully treated as part of trials and special access iASD adult use in Canada, France, Germany, Switzerland, and the United States.

Approximately 90 implantations have been performed to date in the ASCENT ASD pivotal study. The global, prospective, single-arm, multicenter clinical investigation is enrolling up to 250 patients at hospitals in the United States, France, and—after the recent authorizations from Health Canada and Swissmedic—in Canada and Switzerland.

Also, the device has been implanted in nine adult ASD patients in the FIH trial in Germany and in six ASD patients (two adults, four children) in a European registry in Switzerland and Germany, stated the company.