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  • 16 August 2021
    JenaValve Receives IDE Approval to Initiate The ALIGN-AR Pivotal PMA Trial

    JenaValve Technology, Inc., developer, and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced FDA approval for the company to initiate its Investigational Device Exemption (IDE) PMA clinical trial for the Trilogy™ Heart Valve System for severe symptomatic, high-surgical risk aortic regurgitation.

    Aortic regurgitation (AR) is a condition that occurs when a patient’s aortic valve does not close properly, resulting in reverse blood flow from the aorta back into the left ventricle. The current treatment for high surgical risk patients who are not candidates for open-heart surgery consists predominantly of medical management and off-label TAVR.

    “We are pleased the FDA granted this IDE approval allowing us to continue our pursuit of an aortic regurgitation indication for the Trilogy Heart Valve System,” said John Kilcoyne, JenaValve’s CEO. “We believe the Trilogy Heart Valve System’s unique design provides patients with a minimally invasive transfemoral procedure that has the potential to change the treatment paradigm for what I believe is a vastly underdiagnosed and undertreated AR patient population.”

    The ALIGN-AR Pivotal Trial will enroll patients to assess safety and effectiveness of the JenaValve Trilogy™ Heart Valve System in the treatment of high surgical risk patients with symptomatic, severe aortic regurgitation (AR). The study design also allows for patients outside of the US to be included in the trial’s enrollment.

    For additional information on The ALIGN-AR Pivotal Trial, visit: clinicaltrials.gov