Newswise — HACKENSACK, NJ – Hackensack Meridian Health, Hackensack University Medical Center cardiac surgeon Yuriy Dudiy, M.D. became the second in the world to successfully implant the Impella Bridge-to-Recovery (BTR)™ heart pump for the technology’s U.S. Food and Drug Administration (FDA) early feasibility study (EFS) investigational device exemption (IDE). Hackensack University Medical Center is one of only five hospitals in the U.S. selected to participate in the EFS.
Impella BTR, which received FDA IDE approval in December 2021, is a percutaneous forward flow heart pump, with up to greater than six liters of blood flow per minute. Designed to be much less invasive than current left ventricular assist devices (LVADs), Impella BTR is implanted through a small incision in the chest into the axillary artery and sits in the heart’s left ventricle.
Developed by medical technology company Abiomed, Impella BTR is designed to provide patients who have chronic heart failure with a longer-term, minimally invasive heart pump option.
The EFS will evaluate the safety of the Impella BTR and the feasibility of supporting patients until they recover or receive another type of treatment. The EFS will enroll 10 patients at up to five hospitals who will receive Impella BTR support for up to 28 days in the hospital setting. Patients will be securely monitored in the cloud via Impella Connect, giving providers access to Impella BTR status data 24/7. After the study participant no longer requires hemodynamic support, the technology will be weaned and removed. Participants will be followed for 90 days.
“Our selection for participation in this study is evidence of our ongoing commitment to patient care excellence and innovation through advanced technology,” said Kanika Mody, M.D., advanced heart failure cardiologist, medical director of the LVAD service at Hackensack University Medical Center, and principal investigator on the EFS. “Our hospital is pioneering, life-saving technology years before it becomes widely available.” Among only a few in the world to participate in the EFS, which means our patients have access to this innovative technology.
The patient who received the device is a 63 year old male who has been diagnosed with advanced heart failure. The patient received the Impella BTR device on July 18th.
“Hackensack Meridian Health is at the forefront of advances in cardiac care, and we are proud to be selected as one of only a few hospitals in the U.S. to participate in this groundbreaking study,” said David Landers, M.D., Interim Director, Cardiology Division, at Hackensack University Medical Center. “Our research with this investigational device will pave the way for technological advances that lead to improved care for patients with chronic heart failure.”
“This novel technology could change the way we care for chronic heart failure patients by providing less invasive longer-term hemodynamic support with the goal ultimately recovering heart function in very sick patients,” said Mark Anderson, M.D., cardiothoracic surgeon and Chairman, Department of Cardiac Surgery at HUMC..
“Once placed inside the left ventricle, the device is capable of pumping more than six liters of blood per minute,” said Dr. Dudiy. “It could change the way we care for chronic heart failure patients by providing less invasive ventricular assist devices.
Abiomed said that its Impella BTR is smaller in size and less invasive compared to available LVADs, and provides a minimally invasive heart pump option to patients for long-term.
The investigational heart pump is designed to facilitate heart recovery or heart remodeling using adjunctive therapies for patients with class III / IV heart failure.
ABOUT HACKENSACK UNIVERSITY MEDICAL CENTER
Hackensack University Medical Center, a 781-bed nonprofit teaching and research hospital, was Bergen County’s first hospital founded in 1888. It was also 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 from the American Nurses Credentialing Center. The academic flagship of the Hackensack Meridian Health network, Hackensack University Medical Center is Nationally-Ranked by U.S. News & World Report 2022-2023 in four specialties, more than any other hospital in New Jersey. The hospital is home to the state's only nationally-ranked Urology and Neurology & Neurosurgery programs, as well as the best Cardiology & Heart Surgery program. It also offers patients nationally-ranked Orthopedic care and one of the state’s premier Cancer Centers (John Theurer Cancer Center at Hackensack University Medical Center). Hackensack University Medical Center also ranked as High-Performing in conditions such as Acute Kidney Failure, Heart Attack (AMI), Heart Failure, Pneumonia, chronic obstructive pulmonary disease (COPD), Diabetes and Stroke. As well as High Performing in procedures like Aortic Valve Surgery, Heart Bypass Surgery (CABG), Colon Cancer Surgery, Lung Cancer Surgery, Prostate Cancer Surgery, Hip Replacement and Knee Replacement. This award-winning care is provided on a campus that is home to facilities such as the Heart & Vascular Hospital; and the Sarkis and Siran Gabrellian Women’s and Children’s Pavilion, which houses the Donna A. Sanzari Women’s Hospital and the Joseph M. Sanzari Children’s Hospital, ranked #1 in the state and top 20 in the Mid-Atlantic Region in the U.S. News & World Report’s 2022-23 Best Children’s Hospital Report. Additionally, the children’s nephrology program ranks in the top 50 in the United States. Hackensack University Medical Center is also home to the Deirdre Imus Environmental Health Center and is listed on the Green Guide’s list of Top 10 Green Hospitals in the U.S. Our comprehensive clinical research portfolio includes studies focused on precision medicine, translational medicine, immunotherapy, cell therapy, and vaccine development. The hospital has embarked on the largest healthcare expansion project ever approved by the state: Construction of the Helena Theurer Pavilion, a 530,000-sq.-ft., nine-story building, which began in 2019. A $714.2 million endeavor, the pavilion is one the largest healthcare capital projects in New Jersey and will house 24 state-of-the-art operating rooms with intraoperative MRI capability, 50 ICU beds, and 175 medical/surgical beds including a 50 room Musculoskeletal Institute.
ABOUT HACKENSACK MERIDIAN HEALTH
Hackensack Meridian Health is a leading not-for-profit healthcare organization that is 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. The network has 17 hospitals and more than 500 patient care locations, which include ambulatory care centers, surgery centers, home health services, long-term care and assisted living communities, ambulance services, lifesaving air medical transportation, rehabilitation centers, urgent care centers, physician practice locations, and a fitness and wellness center. With more than 35,000 team members and 7,000 physicians, Hackensack Meridian Health is a distinguished leader in health care philanthropy and committed to the health and well-being of communities throughout New Jersey.
The network’s notable distinctions include having more U.S. News-ranked hospitals than any other health system in New Jersey, as ranked by U.S. News & World Report, 2022-23. Hackensack University Medical Center is nationally-ranked by U.S. News & World Report in four specialties, more than any other hospital in New Jersey. Joseph M. Sanzari Children’s Hospital at Hackensack University Medical Center, and K. Hovnanian Children’s Hospital at Jersey Shore University Medical Center, are ranked #1 in the state and top 20 in the Mid-Atlantic Region by U.S. News & World Report’s 2022-23 Best Children’s Hospital Report. Additionally, their combined nephrology program ranks in the top 50 in the United States. To learn more, visit www.hackensackmeridianhealth.org.