Hackensack Meridian Hackensack University Medical Center has announced that they are the first hospital in the nation to successfully implant the world’s first heart failure neuromodulation device, BAROSTIM NEO™. This innovative technology is an effective alternative for patients with Congestive Heart Failure (CHF) who are ineligible for other forms of therapy such as Cardiac Resynchronization Therapy (CRT).
“Hackensack University Medical Center is on the forefront of delivering cutting-edge treatment for our patients,” said Mark D. Sparta, FACHE, president and chief hospital executive, Hackensack University Medical Center and executive vice president of Population Health, Hackensack Meridian Health. “We are proud to be the first hospital in the nation to offer this life-saving, innovative device to improve the quality of life for heart failure patients.”
Patients with CHF suffer from shortness of breath and are limited to mild daily activity. Utilizing the nervous system to treat cardiovascular disease, BAROSTIM NEO offers a groundbreaking treatment alternative for CHF patients. This state-of-the-art device has the unique ability to improve heart performance, reduce hospital readmissions and reduce the amount of medications patients take. It also increases mobility and reduces the risk of infection long-term for patients because it does not have a pump or catheter-like other devices.
“Hackensack University Medical Center is excited to be the first hospital in the country to offer our heart failure patients a promising solution,” said Joseph E. Parrillo, M.D., Chairman, Heart and Vascular Hospital, Hackensack University Medical Center, Professor and Chair, Department of Cardiology, Hackensack Meridian School of Medicine at Seton Hall University. “By utilizing the nervous system to treat heart failure, we now have a pioneering, new way of improving cardiovascular health.”
“This new, innovative technology is a promising alternative for patients suffering from heart failure,” said Massimo M. Napolitano, M.D., FACS, interim chair Department of Surgery, director of Vascular Services, Hackensack University Medical Center. Dr. Napolitano has traveled all over the United States teaching other physicians how to implant BAROSTIM NEO. “Once the device is implanted, complications from the implant procedure are minimal and the patient’s mobility is greatly increased.”
Hackensack University Medical Center has partnered with CVRx since 2006 to participate in U.S. Food and Drug Administration (FDA) approved clinical trials regarding the effectiveness and safety of carotid baroceptor stimulation to treat refractory hypertension. These clinical trials revealed that the device was effective in treating CHF. Hackensack University Medical Center participated in the feasibility trial Hope4HF and the pivotal trial Baroreflex Activation Therapy for Heart Failure Pivotal Trial (BeAT-HF). The positive outcomes of these studies led to the FDA approval of using Baroflex Activation Therapy for treatment of patients with NY Heart Association Functional Class III CHF. This is the first implant in the United States since the device received FDA approval.
“BAROSTIM NEO is revolutionizing the way we treat patients with heart failure,” said Asad Cheema, M.D., Electrophysiologist, Hackensack University Medical Center, who participated in the first implant in the nation at Hackensack University Medical Center. “We look forward to offering our patients an alternative form of therapy that will increase their exercise capability, enhance their quality of life and improve patient outcomes.”
BAROSTIM NEO uses CVRx-patented technology designed to trigger the body’s main cardiovascular reflex to treat patients suffering from chronic heart failure. It is designed to electrically activate the baroreflex, the body’s natural mechanism to regulate cardiovascular function. By activating this afferent pathway, BAROSTIM™ therapy reduces sympathetic activity and increases parasympathetic activity, ultimately restoring autonomic balance.
“BAROSTIM NEO is a groundbreaking solution we can now offer patients with end-stage heart failure who don’t have many other options,” said Michael Wilderman, M.D., FACS, chief, Endovascular Surgery, Hackensack University Medical Center, who also participated in the first implant in the nation at Hackensack University Medical Center. “This novel device improves the quality of life, improves functional status, and it can be done in a relatively minimally invasive fashion.”
CVRx, Inc. is a privately held company founded in 2001 and headquartered in Minneapolis, Minnesota. The company has developed the second-generation BAROSTIM NEO, a minimally invasive implantable system approved for use in heart failure in over 30 countries and approved for use in resistant hypertension in the European Economic Area, Colombia and New Zealand.