atHeart Medical news
The story of the first patient implanted with a reSept ASD Occluder in Switzerland has been reported in Forschungs-Magazin, the research magazine by Children’s Hospital Zurich, where Mathilda’s intervention took place.
In a heartfelt recollection, Mathilda’s family shared their journey from diagnosis, through to coronavirus and travel restrictions, to the operation with a novel device with a metal-free frame, and the welcomed, normal life t
atHeart Medical announced today that it has commenced operations and is initiating its U.S. Investigational Device Exemption (IDE) trial.
The company is led by seasoned global medtech executive, Laurent Grandidier, with support from an exceptional management team that has decades of experience with medical device start-ups and major corporations.
AtHeart Medical’s first
atHeart Medical has received approval for the start of the second phase of its ASCENT ASD U.S. Investigational Device Exemption (IDE) pivotal trial.
The prospective, single-arm study is evaluating the safety and efficacy of the reSept™ ASD Occluder, the first occluder with a metal-free, bioresorbable frame, for the treatment of patients with clinically significant, isolated ASDs. Primary endpoints will be compared with established performance goals f
I couldn’t be more enthusiastic about our purpose at atHeart Medical: allowing more future options for patients with atrial septal defects (ASDs) by reducing device footprint.
Our first product, the reSept ASD Occluder, is the first occluder with a metal-free, bioresorbable frame.
We are focusing on preparing initial clinical sites for our U.S. IDE pivotal trial, the FDA-approved ASCENT-ASD study.
We want to expand the promising data from initial clinical experie