Heart failure patients often suffer from high pressure within the left side of their hearts, which can lead to difficulties breathing and other debilitating conditions. V-Wave, an Israeli firm, won the European CE Mark of approval for its Ventura interatrial shunt that aims to regulate left atrial pressure by creating a passage for blood to flow from the left to the right atrium across the interatrial septum.
The device is implanted during a minimally invasive transcatheter procedure and once there, it allows some blood to flow from the left to the right side of the heart, thereby lowering the pressure and impact of fluid buildup within the lungs.
With hope of receiving FDA approval, the Ventura shunt is currently under study in a randomized, controlled, double-blinded trial (RELIEVE-HF) involving 500 patients at hospitals around the world. Safety and effectiveness will be reviewed in terms of improving morbidity and mortality rates, as well as whether the device leads to a meaningful improvement in the quality of patients’ lives. The study is currently enrolling “advanced [heart failure] patients with preserved or reduced left ventricular ejection fraction who remain symptomatic despite the use of guideline-directed medical and device therapies,” according to V-Wave.
Here’s a video introducing the RELIEVE-HF study:
Product page: V-Wave shunt…