EpicHeart ™ is a soft robotic, non-blood contacting pediatric cardiac assist device to promote heart restoration. The device is delivered with minimal invasion and is pneumatically driven, working in synchrony with the heartbeat and increasing cardiac output through minimal air pressure. PDC funds are being used to scale the current adult prototype to first-in-human use for pediatric patients. NCC-PDI is providing $50,000 in direct funding as well as a regulatory, preclinical animal model and study design expertise. This is a Class III device, with projected Humanitarian Device Exemption (HDE) path.
Year:
2017
Anticipated Classification:
Class III
Anticipated Regulatory Path:
HDE
Initial Development Stage:
Pre-Clinical
Current Development Stage:
Pre-Clinical
