WASHINGTON — An implanted cardiac neuromodulator that provides baroreflex stimulation in patients with hard-to-treat advanced heart failure won FDA approval, the agency announced late Friday.
The Barostim Neo System is indicated for improving symptoms in patients “who are not suited for treatment with other heart failure devices, such as cardiac resynchronization therapy,” the FDA said.
Left ventricular ejection fraction should be no greater than 35% to be eligible for the Barostim system.
“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, MD, director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, in the agency’s approval announcement.
The system includes a pulse generator implanted below the clavicle, with leads attached to the carotid artery where a current is delivered to so-called baroreceptors. “The brain, in turn, sends signals to the heart and blood vessels that relax the blood vessels and inhibit the production of stress-related hormones to reduce heart failure symptoms,” the FDA statement explained.
Approval was heavily influenced by a study showing improved quality of life and heart function, as well as favorable effects on the biomarker NT-proBNP.
The Barostim product comes with some risk of adverse effects, including potential need for revision surgery, infections, hypotension, nerve or vascular damage, and allergic reactions, the FDA noted. Contraindications include anatomic features incompatible with device placement, uncontrolled bradycardia, atherosclerotic or ulcerative plaques near the implant site, and known allergy to silicone or titanium.
CVRx Inc. sells the Barostim Neo System.
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Source: MedicalNewsToday.com
