V-Wave Receives CE Mark for the Ventura Interatrial Shunt System

March 5, 2020—V-Wave Ltd., a developer of implantable devices for the treatment of heart failure (HF), announced that its Ventura interatrial shunt system received CE Mark approval for use in the European Union.

In the United States, the Ventura device is an investigational device being evaluated in the RELIEVE-HF pivotal trial being conducted under an investigational device exemption from the FDA.

According to the company, the global, randomized controlled, double-blinded RELIEVE-HF trial is designed to demonstrate the safety and effectiveness of shunt therapy in reducing HF morbidity and mortality and improving functional status. The study is enrolling advanced HF patients with preserved or reduced left ventricular ejection fraction who remain symptomatic despite the use of guideline-directed medical and device therapies. RELIEVE-HF will be composed of 500 patients with the participation of approximately 100 hospitals in North America, Europe, and Israel.

In addition to developing interatrial shunt device technologies for the treatment of heart failure, V-Wave is exploring the use of its interatrial shunt device technologies for the treatment of pulmonary arterial hypertension in the RELIEVE-PAH early feasibility study conducted under an FDA investigational device exemption.

In 2019, the company received FDA Breakthrough Device designations for its interatrial shunt technology for both heart failure and pulmonary arterial hypertension.