June 10, 2013 — Direct Flow Medical Inc. announced that it has received approval from the U.S. 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 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.
Post-procedural aortic regurgitation following transcatheter aortic heart valve replacement (TAVR) has been shown to be a predictor of long-term mortality. The Direct Flow Medical Transcatheter Aortic Valve System is designed to address this clinical concern by enabling in-situ hemodynamic assessment after the valve is fully deployed in the native valve annulus, as well as limitless repositioning with full distal, proximal and planar control, or retrieval, if required. The system avoids rapid pacing of the heart during deployment and post-dilatation following placement, minimizing the risk of hemodynamic stress for patients.
With receipt of IDE approval, Direct Flow Medical plans to commence its U.S. clinical study evaluating the use of the Direct Flow Medical Transcatheter Aortic Heart Valve System. The system includes a distinctive heart valve with a metal-free frame that will be delivered transfemorally via a flexible, 18 French delivery system. The SALUS Trial is a 30-patient feasibility trial that will be conducted at up to six U.S. clinical sites.
Six-month results from the company’s DISCOVER CE Mark Trial presented at the American College of Cardiology (ACC) 2013 Annual Meeting, which studied the Direct Flow Medical system, demonstrated excellent survivability, sustained hemodynamic improvements and few adverse events, with minimal occurrence of aortic regurgitation.
The Direct Flow Medical system received the CE Mark in January 2013 and is currently available commercially in Europe.
For more information: www.directflowmedical.com