August 19, 2019
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FDA approves baroreflex activation therapy for advanced HF

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The FDA has approved the Barostim Neo System for the improvement of symptoms in patients with advanced HF who are not suited for treatment with other HF devices, such as cardiac resynchronization therapy. The FDA gave the device a Breakthrough Device designation, according to an agency press release.

The baroreflex activation therapy system (CVRx Inc.) is indicated for patients with regular heart rhythm who are not candidates for cardiac resynchronization therapy and have a left ventricular ejection fraction of 35% or less.

“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,” Bram Zuckerman, MD, director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, said in the release. “This approval provides patients with a new treatment option for the symptoms associated with advanced heart failure.”

The Barostim Neo System includes a pulse generator that is implanted below the collar bone, connected to a lead that attaches the device to the carotid artery to deliver electrical impulses to baroreceptors that sense blood flow through the carotid arteries. Once a physician tests and programs the device after implantation, the baroreceptors receive the electrical impulses and signal the brain, which then signals to the heart and blood vessels that relaxes the vessels, inhibiting the production of stress-related hormones and reducing HF symptoms, according to the release.

Approval was based on a prospective, multicenter, two-arm, randomized clinical trial of 408 patients with advanced HF who received guideline-directed medical therapy and/or baroreflex activation therapy. In this study, those who received the implant had improvements in 6-minute walk distance and quality of life. In addition, 102 participants with less-severe HF improvements in N-terminal pro-B natriuretic peptide levels.

The device was approved using the Premarket Approval (PMA) pathway. As part of the approval of this device, the FDA is requiring the manufacturer to conduct a post-approval study investigating the potential of the therapy to prolong life and reduce the need for patient hospitalization, according to the release. – by Scott Buzby

Disclosure: Zuckerman is director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health.