AtHeart Medical today announced positive long- and short-term clinical outcomes for its reSept atrial septal defect (ASD) occluder. Data from three patient cohorts showed positive efficacy and safety outcomes for the occluder, which features a bioresorbable, metal-free frame. AtHeart says it's the first ASD occluder with this kind of frame. It … [Read more...] about AtHeart Medical reports positive data for ASD occluder with bioresorbable frame
atHeart Medical
AtHeart Medical wins FDA approval for second phase of ASD occluder IDE study
AtHeart Medical recently announced that it received FDA approval to commence the second phase of its Ascent ASD investigational device exemption pivotal trial. Switzerland-based AtHeart Medical is evaluating the safety and efficacy of the reSept atrial septal defects (ASD) occluder in a prospective, single-arm study. The reSept device is … [Read more...] about AtHeart Medical wins FDA approval for second phase of ASD occluder IDE study
atHeart Medical launches atrial septal defect occluder trial
AtHeart Medical is initiating a U.S. investigational device exemption trial for its atrial septal defects (ASD) occluder. The reSept ASD Occluder is an occluder with a metal-free, bioresorbable frame. The implant is designed to overcome the limitations of occluders by reducing the risk of complications associated with the long-term presence of … [Read more...] about atHeart Medical launches atrial septal defect occluder trial
