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 product, the reSept ASD Occluder, is the first occluder with a metal-free, bioresorbable frame. The novel implant is poised to overcome the limitations of current occluders, as it aims to reduce the risk of complications associated with the long-term presence of metal in the heart and to preserve future treatment options requiring transseptal intervention. Initial clinical experience demonstrates long-term clinically effective closure of the ASDs treated with the company’s device.1
“I am excited to lead atHeart Medical and for the potential of our first product, the reSept ASD Occluder, for patients requiring ASD closure,” commented Laurent Grandidier, CEO of atHeart Medical. “With such an experienced team, we have hit the ground running and are focused on preparing initial clinical sites in our U.S. IDE pivotal trial.”
1. Company Data on File.