Hackensack University Medical Center Second Hospital Worldwide to Implant Impella BTR Minimally Invasive Heart Pump
One of only five sites in the U.S. selected to participate in early clinical trial for the minimally invasive Advanced HF technology
Hackensack Meridian Hackensack University Medical Center cardiac surgeon Yuri 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 study. Impella BTR, which received FDA IDE approval in Dec. 2021, is a percutaneous forward-flow heart pump, with 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 check 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 investigational heart pump is designed to facilitate heart recovery or heart remodeling using adjunctive therapies for patients with class III/IV heart failure.
Impella BTR is a forward-flow heart pump designed to be implanted through the axillary artery and placed in the left ventricle. Dr. Dudiy implanted the device in a 63-year-old male diagnosed with advanced heart failure in July 2022.
“Once placed inside the left ventricle, the device is capable of pumping more than six liters of blood per minute,” said Kanika Mody, M.D., Advanced Heart Failure, VAD and Transplant Specialist at Hackensack University Medical Center and primary investigator of the study. “It could change the way we care for chronic heart failure patients by providing less invasive care.”
The EFS will evaluate the safety of 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. Once the study participant no longer requires hemodynamic support, the technology will be weaned and removed. Participants will be followed for 90 days.
Learn more about innovative heart and vascular care at Hackensack University Medical Center.
