• Heart failure shunt receives FDA’s breakthrough designation

    • August 19, 2019
    • Posted By : admin
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    The V-Wave device is designed to help treat the two types of left-sided heart failure in patients who remain symptomatic after treatment with guideline-directed medical and device therapies.

    More than six million people in the United States are living with chronic heart failure. Left atrial pressure is the most common reason for exercise limitation and hospitalizations among chronic heart failure patients, sending more than three million people to the hospital every year.

    For patients who have heart failure with reduced ejection fraction, the heart can’t pump with enough force to push an adequate amount of blood into circulation. In the second type, called heart failure with preserved ejection fraction, the left ventricle becomes stiff and can’t properly fill with blood during the resting period between beats.

    The shunt is designed to prevent episodes of elevated left atrial pressure and therefore decrease hospitalizations, increase exercise tolerance, improve quality of life and potentially extend survival, the company said.

    V-Wave said it will evaluate the safety and effectiveness of the device in a global, randomized, controlled, double-blinded pivotal study of 500 patients called RELIEVE-HF. Patients are being enrolled in North America, Europe and Israel.

    V-Wave’s Series C financing round, which closed in April 2018, was led by Deerfield Management. Healthcare funds Endeavour Vision, Quark Venture and Aperture Venture Partners were new investors. V-Wave’s existing major investors also participated in the round, including Johnson & Johnson Innovation, Edwards Lifesciences, BRM Group, Pontifax, Pura Vida Investments, TriVentures, BioStar Ventures, and Israel Secondary Fund.

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