The U.S. Food and Drug Administration has approved medical device company CVRx Inc.'s implant for certain patients with advanced heart failure.
Heart failure characterizes a condition in which the heart cannot pump enough blood to meet the body's needs.
Minnesota-based CVRx's Barostim Neo System is authorized for 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 — a treatment to help the heart beat with the right rhythm.
The Barostim Neo System includes a pulse generator that is implanted below the collar bone and helps inhibit the production of stress-related hormones to reduce heart failure symptoms.
CVRx's device was approved under the FDA's premarket approval pathway — the regulator's process of scientific and regulatory review to evaluate the safety and effectiveness of certain medical devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential unreasonable risk of illness or injury.
The FDA said it evaluated data from a 408-patient clinical trial where all patients had advanced heart failure and had received guideline-directed medical therapy, including medication, and 125 patients also received a Barostim Neo System implant.
Data from the trial showed that patients with the implant demonstrated 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.
CVRx's Barostim Neo System had received a breakthrough device designation from the U.S. regulator because it treats a life-threatening disease and deals with an unmet medical need in patients who do not benefit from standard treatments and have no alternative treatment options. About 5.7 million people in the U.S. have heart failure, according to the FDA's Aug. 16 news release.