FDA approves Barostim Neo System for heart failure

The FDA has approved the Barostim Neo System, from CVRx, 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 have no alternative treatment options. The device was approved using the Premarket Approval (PMA) pathway.

The FDA evaluated data from a prospective, multi-center, two-arm, randomized clinical trial with a total of 408 patients with advanced heart failure. All patients received guideline-directed medical therapy, including medication, and 125 patients also received a Barostim Neo System implant. Patients receiving the implant showed improvements in the distance they were able to walk in six-minute walking tests and improvements in how symptoms impacted their quality of life. Also in the trial, 102 randomized subjects with less severe chronic heart failure found benefit in lowering levels of a biomarker that measures heart failure.

Potential complications associated with the implantation or use of the device include: infection; need for reoperation; low blood pressure that may cause dizziness, fainting, and/or falls; nerve damage; surgical or anesthetic complications; allergic reaction; arterial damage; exacerbation of heart failure; stroke; and death.