CVRx Announces FDA Approval of BAROSTIM NEO Neuromodulation Device for Heart Failure Treatment

On August 19, 2019, VCBeat (WeChat ID: vcbeat) learned from foreign media reports that medical device company CVRx announced its heart failure neuromodulation device, BAROSTIM NEO, had received FDA approval for market launch, to be used for neuromodulation therapy in patients with advanced heart failure.

Heart failure is a serious condition that causes symptoms such as declining cardiac function, shortness of breath, exercise intolerance, and fluid retention. In the United States, approximately 6.5 million adults are affected by heart failure, one in every eight deaths is related to heart failure, and nearly half of heart failure patients die within five years of diagnosis. The total cost of treating heart failure in the United States is projected to rise to $69.7 billion by 2030.

BAROSTIM NEO utilizes CVRx’s proprietary technology to activate the baroreflex via electrical field stimulation, helping the body restore its natural mechanisms of cardiovascular regulation for the treatment of patients with chronic heart failure. The device reduces sympathetic nervous activity and increases parasympathetic nervous activity, ultimately restoring autonomic neural balance.

BAROSTIM NEO is one of the first devices to receive the FDA’s “Breakthrough Device” designation. The “Breakthrough Device” designation applies to effective therapies for life-threatening diseases. With this designation, clinical trials for BAROSTIM NEO will receive priority review by the FDA, helping to accelerate its development and approval process.

Phase II clinical trials of BAROSTIM NEO demonstrated that, after six months of treatment, patients receiving BAROSTIM NEO therapy exhibited significant improvements in both quality of life and cardiovascular function compared to those in the control group.

CVRx, a medical device company founded in 2001 and headquartered in Minneapolis, Minnesota, USA, is dedicated to developing implantable technologies for the treatment of hypertension. CVRx’s vision is to enable every patient to enjoy a fuller and healthier life. The company has pioneered unique therapies that improve patient outcomes by harnessing the body’s natural systems. CVRx’s product portfolio includes the Rheos Implantable Pulse Generator and the Rheos Carotid Sinus Lead.

Dr. Michael Zile, Professor of Medicine at Southern Medical University, stated, “Following FDA approval of BAROSTIM NEO, patients with advanced heart failure who are not candidates for cardiac resynchronization therapy (CRT) can receive effective neuromodulation therapy, leading to significant improvements in their quality of life and exercise capacity.”

Nadim Yared, President of CVRx, stated, “Throughout decades of research and development in the field of neuromodulation, BAROSTIM NEO is the first FDA-approved device that leverages the brain and nervous system’s regulatory mechanisms to treat cardiovascular disease. We are delighted that the company is entering its next phase of growth. CVRx will further develop and promote BAROSTIM NEO, bringing innovative therapeutic solutions to patients with chronic heart failure.”

(Compiled by Hu Yifan)