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."
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.