The US Food and Drug Administration (FDA) has granted breakthrough device designation to V-Wave’s interatrial shunt for the treatment of patients with symptomatic heart failure (HF).
The investigational, miniature, minimally invasive device is meant to relieve increased left atrial pressure (LAP), in turn decreasing fluid build-up in the lungs.
According to the company, fluid build-up in the lungs is considered as the most common reason for HF hospitalisations and exercise limitation.
The V-Wave interatrial shunt is meant for chronic HF patients with preserved and reduced ejection fraction.
It is designed to prevent elevated LAP episodes, thereby offering symptom relief, minimising hospitalisation, and improving exercise tolerance and quality of life.
V-Wave CEO Neal Eigler said: “This breakthrough designation provides V-Wave with additional options for FDA communication that will facilitate collaboration, as well as a prioritised review of submissions and marketing applications.
“The potential for early Centers for Medicare and Medicaid Services (CMS) support for this programme, makes our breakthrough designation a double-win for HF patients who need access to novel therapies as quickly as possible.”
The interatrial shunt is currently undergoing a global, randomised, double-blinded, controlled investigational device exemption (IDE) clinical trial called RELIEVE-HF.
RELIEVE-HF will involve 500 advanced HF patients with preserved or reduced left ventricular ejection fraction. The trial will enrol subjects who experience symptoms even after prior medical and device therapies.
It will assess the safety and effectiveness of the V-Wave interatrial shunt at up to 75 sites in the US, Canada, Europe and Israel.
The trial will also measure the six-minute walk test (6MWT) and change in the Kansas City Cardiomyopathy Questionnaire (KCCQ). RELIEVE-HF is expected to be completed in 2025.