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Hackensack Becomes First Hospital in Nation to Implant World’s First Heart Failure Neuromodulation Device

CardiologyHackensack University Medical Center

What you need to know

Hackensack University Medical Center has now become 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).

More details on Neuromodulation device

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.

“This new, innovative technology is a promising alternative for patients suffering from heart failure. Once the device is implanted, complications from the implant procedure are minimal and the patient’s mobility is greatly increased.”

Massimo M. Napolitano, M.D., FACS, interim chair Department of Surgery, director of Vascular Services, Hackensack University Medical Center.

Hackensack 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 also 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 a groundbreaking solution we can now offer patients with end stage heart failure who don’t have many other options. This novel device improves quality of life, improves functional status, and it can be done in a relatively minimally invasive fashion.”

Michael Wilderman, M.D., FACS, chief, Endovascular Surgery, Hackensack University Medical Center