LivaNova to Present Autonomic Regulation Therapy Findings for Heart Failure During European Society of Cardiology Congress 2019

LivaNova to Present Autonomic Regulation Therapy Findings for Heart Failure During European Society of Cardiology Congress 2019

Autonomic Regulation Therapy (ART) novel approach to treating failure, international, controlled clinical (ANTHEM-HFrEF Pivotal LivaNova to Present Study). “At ANTHEM-HFrEF evaluating how our could improve care for with chronic failure, General Manager Neuromodulation. “We are encouraged by results from our pilot potential impact this therapeutic innovation. ” The received CE Mark in 2015 has granted Expedited Access Pathway breakthrough technology by U. S. Food Drug Administration (FDA). approved by FDA.

The U. S. Food and Drug Administration today approved the Barostim Neo System for the improvement of symptoms in patients with advanced heart failure who are not suited for treatment with other heart failure devices, such as cardiac resynchronization therapy. The FDA gave the device a Breakthrough Device designation because it treats a life-threatening disease, heart failure, and addresses an unmet medical need in patients who fail to get adequate benefits from standard treatments and chronic heart failure symptoms have no alternative treatment options. “Patients with advanced heart failure have limitations of physical activity, experiencing fatigue, palpitation or shortness of breath with activity and may not benefit from standard treatments, including currently marketed drugs and devices. This approval provides patients with a new treatment option for the symptoms associated with advanced heart failure,” said Bram Zuckerman, M. D. , director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health.

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