Direct Flow Medical, Inc., a transcatheter heart valve company focused on improving patient outcomes, today announced that it has received approval from the United States Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) to begin the SALUS feasibility trial of the Direct Flow Medical Transcatheter Aortic Heart Valve System.
The device encompasses a distinctive transcatheter aortic heart valve with a metal-free frame and flexible, low-profile delivery system that virtually eliminates aortic regurgitation. It is designed to improve the long term survivability of patients by resolving the clinical issues associated with current commercial valves.
Read the press release