The minimally invasive, implanted device, V-Wave's Interatrial Shunt, has been developed to treat patients with symptomatic Heart Failure (HF).
The device creates a passageway connecting the heart's two atria. The shunt is designed to help regulate high pressure in the left atrium by allowing excess blood to flow between the chambers, as the high pressure can lead to the buildup of fluid in the lungs and difficulty in breathing.
The shunt is meant to relieve increased Left Atrial Pressure (LAP), thereby decreasing fluid build-up in the lungs. The fluid buildup in the lungs is considered as the main reason for HF hospitalisations and exercise limitations.
The interatrial shunt is meant for chronic HF patients with preserved and reduced ejection fraction.
In case of patients who have HF with reduced ejection fraction, the heart cannot pump with enough force to push an adequate amount of blood into circulation whereas, for patients who have HF with preserved ejection fraction, the left ventricle becomes stiff and cannot properly fill with blood during the resting period between beats.
The device is designed to prevent elevated LAP, thus providing symptom relief, minimizing hospitalization, improving exercise tolerance and quality of life.
A global, randomized, controlled, double-blinded Investigational Device Exemption (IDE) trial called RELIEVE-HF is being currently done on the interatrial shunt. The trial will involve 500 advanced HF patients with preserved or reduced left ventricular ejection fraction. It will also enroll subjects who experience symptoms even after prior medical and device therapies. RELIEVE-HF is expected to be completed in 2025.
Interatrial shunt has been granted a breakthrough device designation by the US Food and Drug Administration.
