New Device Improves Advanced Heart Failure Symptoms

The system consists of an implantable pulse generator inserted under the skin, below the collar bone; a two mm electrode attached to the carotid artery and connected to an implantable pulse generator (IPG), which triggers the baroreceptors via electrical stimulation; and a wireless programmer that enables the clinician to customize therapy by adjusting hemodynamic parameters.

The system is indicated for patients who have a regular heart rhythm, are not candidates for a cardiac resynchronization therapy (CRT) device, and have a left ventricular ejection fraction (LVEF) of less than or equal to 35% (below the normal ejection fraction of 55-75%). The device is contraindicated in patients with an anatomy that would impair implantation of the device, certain nervous system disorders, an uncontrolled and symptomatic slow heart rate, atherosclerosis or ulcerative plaques near the implant location, and in patients with a known allergy to silicone or titanium.

“Patients with advanced HF 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,” said Bram Zuckerman, MD, of the U.S. Food and Drug Administration (FDA; Silver Spring, MD, USA) Center for Devices and Radiological Health (CDRH). “This approval provides patients with a new treatment option for the symptoms associated with advanced heart failure.”

Baroreceptors are stretch-sensitive fibers located in the aortic arch and the carotid artery sinus. Their activation triggers an afferent nerve action potential negative-feedback signal to the medulla that helps to maintain normal arterial pressure. When working normally, they buffer fluctuations in blood pressure by causing reflex-mediated reciprocal changes in both heart rate and sympathetic nerve activity, thereby keeping the level of arterial pressure at a predetermined operating level. However, in patients with chronic hypertension, the elevations in pressure threshold can result in decreased baroreceptor activity.

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