JenaValve Technology has launched a new Pericardial Transcatheter Aortic Valve Replacement (TAVR) system.
The device is used for the treatment of severe Aortic Regurgitation (AR) and AR-dominant mixed aortic valve disease, a life-threatening and seriously debilitating condition, in patients at high risk for surgery.
This technology does not require rapid pacing, unlike other TAVR designs.
The TAVR system is intended to enable ease of use, reduced risks of paravalvular regurgitation and the need for permanent pacing and durability of patient hemodynamic outcomes.
The TAVR system includes a self-expanding nitinol stent with a porcine pericardial valve manufactured using state-of-the-art tissue processing procedures.
Moreover, the TAVR system is available in three sizes to treat a wide range of aortic annulus diameters.
The JenaValve pericardial TAVR system is an investigational device that is not available for sale in the US or internationally.
The breakthrough designation for the device was obtained from the US Food and Drug Administration (FDA).