Yuriy Dudiy MD Becomes Second in the World to Implant New Heart Pump
What You Need to Know
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.
The Impella BTR, 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.
About the Study
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.
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.
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.