Abiomed (Nasdaq:ABMD) today announced the first patient in the world was successfully treated with its Impella Bridge-to-Recovery (BTR) as part of an early feasibility study.
The first implant was performed by Dr. Duc Thinh Pham and Dr. Jane Wilcox at Northwestern Medicine Bluhm Cardiovascular Institute in Chicago.
Impella BTR is a forward flow heart pump that is implanted through the axillary artery and is placed in the left ventricle. Danvers, Massachusetts-based Abiomed designed the implant to pump more than six liters of blood per minute. According to the company, Impella BTR is less invasive than some left ventricle assist devices (LVADs) and can allow patients with chronic heart failure to have a longer-term minimally invasive heart pump option.
“Bluhm Cardiovascular Institute at Northwestern Medicine is pleased to be the first in the world to implant Impella BTR as part of this important study,” said Dr. Wilcox, chief of heart failure treatment and recovery at Northwestern Medicine. “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 of ultimately improving heart function in very sick patients.”
The implant is designed to allow for heart recovery or heart remodeling with adjunctive therapies for patients with class III and class IV heart failure. Abiomed’s Impella BTR development program will also give patients a home discharge and more than one year of full hemodynamic support.
In the FDA early feasibility study, Abiomed is evaluating the safety of the Impella heart pump’s BTR in patients who require left ventricular hemodynamic support, as well as the feasibility of supporting patients to recovery or their next therapy. The initial study will enroll 10 patients at five hospitals who will receive Impella BTR support for up to 28 days in a hospital setting, according to the company.
Patients in the study will be securely monitored with cloud connectivity through Impella Connect to give healthcare providers access to continuous Impella BTR status data. The device will be weaned and removed once study participants no longer require hemodynamic support.
“The first implant of Impella BTR is an important step toward our goal of improving patient care by providing a longer-term minimally invasive forward flow smart heart pump option with home discharge for patients with chronic heart failure,” CEO Michael Minogue said in a news release. “Overall, Abiomed is creating the innovation for the field of heart recovery and solving a healthcare crisis for this patient population with advanced research and technology.”