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 metal-free with a bioresorbable frame designed to treat patients with clinically significant, isolated ASDs. AtHeart Medical will compare the primary endpoints with established performance goals for other FDA-approved transcatheter ASD occluders.
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