CVRx, a Maple Grove-based medical device company, has secured approval for its implantable technology – Barostim Neo System from the US Food and Drug Administration (FDA) to improve symptoms in patients with advanced heart failure.
As per the FDA approval for the CVRx Barostim Neo System, the medical device has to be used in patients with advanced heart failure who are not suitable for treatment with cardiac resynchronization therapy and other heart failure devices.
The heart failure device was given a Breakthrough Device designation by the FDA as it is intended for use in the treatment of a life-threatening disease, in this case – heart failure. Furthermore, the CVRx heart failure device addresses an unmet medical need in patients who cannot get sufficient benefits from standard treatments and have no alternative treatments, said the FDA.
Commenting on the FDA approval for the CVRx Barostim Neo System, Bram Zuckerman – director of the Office of Cardiovascular Devices in the FDA Center for Devices and Radiological Health, said: “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.
“The FDA continues to work with manufacturers through our Breakthrough Devices Program to provide patients and health care providers with timely access to medical devices that have the potential to lead to a clinical improvement in patients, such as those with this irreversibly debilitating condition, while ensuring these devices meet our regulatory requirements for safety and effectiveness.”
The CVRx Barostim Neo System comes with a pulse generator that is implanted under the collar bone and is linked to a lead that attaches to the carotid artery in the neck.
Once the heart failure device is implanted, a physician tests and programs it, following which electrical impulses are delivered to cells in the neck known as baroreceptors, which sense how blood is flowing in the carotid arteries and relays information to the brain. In turn, the brain transmits signals to the heart and blood vessels that relax the blood vessels and prevent the production of stress-related hormones to alleviate heart failure symptoms.
The FDA approval for the CVRx Barostim Neo System is based on the data from a multi-center, two-arm, randomized clinical trial – the BeAT-HF phase 3 study featuring 408 patients with advanced heart failure. All patients in the BeAT-HF phase 3 clinical trial were subjected to guideline-directed medical therapy, including medication, while 125 patients had the Barostim Neo System implanted.
Patients with the CVRx heart failure device in the BeAT-HF phase 3 clinical trial had improvements in the distance they were able to walk in six-minute walking tests and improvements in how the symptoms affected their quality of life. What was also found from the clinical trial was that 102 randomized subjects with less severe chronic heart failure found benefit in reducing levels of a biomarker that measures heart failure.
According to the FDA, the CVRx Barostim Neo System is indicated to be used in patients with a regular heart rhythm, are not suitable for cardiac resynchronization therapy, and have a left ventricular ejection fraction of under or equal to 35%, which is considered less than the normal ejection fraction of 55-75%.
The CVRx heart failure device is not indicated for patients with anatomy that would impair its implantation, and also for some nervous system disorders, uncontrolled and symptomatic slow heart rate, atherosclerosis or ulcerative plaques present near the implant location and patients having a known allergy to silicone or titanium.
Nadim Yared – President and CEO of CVRx, commenting on the Barostim Neo System FDA approval, said: “After many decades of research in the field of neuromodulation, the BAROSTIM NEO is the first device approved in the United States that uses the power of the brain and nervous system to target cardiovascular disease.
“We are thrilled to transition to the next stage of our company’s growth, shifting our focus to the successful adoption of BAROSTIM NEO in the United States and bringing an innovative solution to chronic heart failure patients.”
The CVRx Barostim Neo System was approved by the FDA using the Premarket Approval (PMA) pathway, based on a determination by the regulator that the PMA application has enough valid scientific evidence to offer reasonable assurance that the device is safe and effective for its intended uses.
As part of the approval of the Barostim Neo System, the regulator needs CVRx to undertake a post-approval study to investigate the potential of the heart failure device to prolong life and cut down the necessity for patient hospitalization.