Direct Flow Medical (Santa Rosa, CA) received European CE Mark approval for its new transfemoral delivery system used for placing the company’s Transcatheter Aortic Valve System. The device is able to deliver any of the valves, regardless of size, using the same low-profile sheath that can move through vessels down to 5.2 mm in luminal diameter.
The new generation of the delivery system has improved ergonomics and offers more precision and control when placing a valve. Because of the design of the valve and the functionality of the delivery system, the implant can be repositioned as often as necessary to achieve optimal placement within the diseased natural heart valve.
The Direct Flow valves are currently approved for clinical use in Europe, and in the U.S. the company is currently enrolling patients into a pivotal trial the results of which will determine whether they get cleared in the U.S.
Here’s an animation describing the Direct Flow Transcatheter Aorticl Valve System:
Flashbacks: DirectFlow Medical’s Transcatheter Aortic Valves Now Down to 23mm and Installed Contrast-Free (VIDEO)…; Direct Flow Medical’s 29mm Repositionable Transcatheter Aortic Valve Cleared in EU…; Direct Flow Transcatheter Aortic Heart Valve Gets FDA Feasibility Trial OK (VIDEO)…; Direct Flow Medical Transcatheter Aortic Valve Does Well in Clinical Study…; Catheter Delivered Aortic Valve from Direct Flow Medical Wins European Clearance (w/video)…