Hackensack Meridian Hackensack University Medical Center First Hospital in Nation to Implant World's First Heart Failure Neuromodulation Device

BAROSTIM NEO™ provides effective treatment for heart failure patients

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Feb 03, 2020, 09:10 ET

HACKENSACK, N.J., Feb. 3, 2020 /PRNewswire/ -- Hackensack Meridian Hackensack University Medical Center announced today that it is 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 Meridian Hackensack University Medical Center announced it is the first hospital in the nation to successfully implant the world’s first heart failure neuromodulation device, BAROSTIM NEO™, pictured above. Picture provided by CVRx.

"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 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.

About Hackensack Meridian Hackensack University Medical Center
Hackensack Meridian Hackensack University Medical Center, a 781-bed nonprofit teaching and research hospital located in Bergen County, NJ, is the largest provider of inpatient and outpatient services in the state. Founded in 1888 as the county's first hospital, it is now part of the largest, most comprehensive and truly integrated health care network in New Jersey, offering a complete range of medical services, innovative research and life-enhancing care, which is comprised of 35,000 team members and more than 7,000 physicians. Hackensack University Medical Center is ranked #2 in New Jersey and #59 in the country in U.S. News & World Report's 2019-20 Best Hospital rankings and is ranked high-performing in the U.S. in colon cancer surgery, lung cancer surgery, COPD, heart failure, heart bypass surgery, aortic valve surgery, abdominal aortic aneurysm repair, knee replacement and hip replacement. Out of 4,500 hospitals evaluated, Hackensack is one of only 57 that received a top rating in all nine procedures and conditions. Hackensack University Medical Center is one of only five major academic medical centers in the nation to receive Healthgrades America's 50 Best Hospitals Award for five or more years in a row. Becker's Hospital Review recognized Hackensack University Medical Center as one of the 100 Great Hospitals in America 2018. The medical center is one of the top 25 green hospitals in the country according to Practice Greenhealth, and received 26 Gold Seals of Approval™ by The Joint Commission – more than any other hospital in the country. It was the first hospital in New Jersey and second in the nation to become a Magnet® recognized hospital for nursing excellence; receiving its sixth consecutive designation in 2019. Hackensack University Medical Center has created an entire campus of award-winning care, including: John Theurer Cancer Center, a consortium member of the NCI-designated Georgetown Lombardi Comprehensive Cancer Center; the Heart & Vascular Hospital; and the Sarkis and Siran Gabrellian Women's and Children's Pavilion, which houses the Joseph M. Sanzari Children's Hospital and Donna A. Sanzari Women's Hospital, which was designed with The Deirdre Imus Environmental Health Center® and listed on the Green Guide's list of Top 10 Green Hospitals in the U.S. Hackensack University Medical Center is the Hometown Hospital of the New York Giants and the New York Red Bulls and is Official Medical Services Provider to THE NORTHERN TRUST PGA Golf Tournament. It remains committed to its community through fundraising and community events especially the Tackle Kids Cancer Campaign providing much needed research at the Children's Cancer Institute housed at the Joseph M. Sanzari Children's Hospital. To learn more, visit www.HackensackUMC.org.