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 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