The new device will treat patients who are not suited for other commonly used treatment options for advanced heart failure.
Patients with advanced heart failure will soon have a new implantable device in the Barostim Neo System.
The US Food and Drug Administration (FDA) announced the device was given the Breakthrough Device designation because it treats a life-threatening disease, while addressing an unmet medical need in patients who fail to get adequate benefits from standard treatments such as cardiac resynchronization therapy without alternative treatment options. The device was approved using the Premarket Approval (PMA) pathway, the most stringent type of device marketing application.
“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 a statement. “This approval provides patients with a new treatment option for the symptoms associated with advanced heart failure.”
The Barostim Neo System, developed by CVRx, includes a pulse generator that is implanted below the collar bone, connected to a lead that attaches to the carotid artery in the neck. Once implanted the device is tested and programed to deliver electrical impulses to cells in the neck called baroreceptors, which sense how blood is flowing through the carotid arties and relay information to the brain.
The brain then sends signals to the heart and blood vessels that relax the blood vessels and inhibit stress-related hormone production to reduce heart failure symptoms.
The FDA evaluated data from a prospective, multi-center, 2-arm, randomized clinical trial with a total of 408 patients with advanced heart failure, where patients received guideline-directed medical therapy, including medication. In addition, 125 patients received a Barostim Neo System implant.
Patients receiving the implant showed improvements in the distance they were able to walk in 6-minute walking tests and improvements in how symptoms impacted their quality of life, while 102 randomized subjects with less severe chronic heart failure saw lowered 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.
The Barostim Neo System is indicated for patients who have a regular heart rhythm, are not candidates for cardiac resynchronization therapy, and have a left ventricular ejection fraction of less than or equal to 35%, which is considered below the normal ejection fraction of 55 to 75%.
According to FDA estimates, approximately 5.7 million people in the US suffer from heart failure from a number of causes, including diseases that damage the heart, such as high blood pressure and diabetes.
Some of the commonly treatment options including treating the underlying causes and reducing symptoms such as fatigue and swelling in the lower extremities that make physicals activity challenging.
Medications such as angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers and beta blockers to lower blood pressure and reduce strain on the heart, as well as diuretics to reduce fluid buildup in the lungs and swelling in the feet and ankles are also often prescribed.