Implantable circulatory support devices maker Abiomed has announced the implantation of first patient with its Impella Bridge-to-Recovery (BTR) minimally-invasive heart pump.
The first implant procedure was performed by Duc Thinh Pham and Jane Wilcox, at Northwestern Medicine Bluhm Cardiovascular Institute.
It was a part of the BTR heart pump’s US Food and Drug Administration (FDA) Early Feasibility Study (EFS) in people suffering from severe heart failure.
The EFS aims to assess the safety of Impella BTR in patients needing left ventricular hemodynamic support, along with the feasibility of the device in supporting patients’ recovery or next therapy.
The initial study is planned to enrol 10 patients at five hospitals who will receive Impella BTR support for up to 28 days within a hospital setting.
In the study, participants will be securely monitored in the cloud through Impella Connect, enabling healthcare providers to access the Impella BTR status data round the clock.
Once the study participant no longer requires hemodynamic support, the implant will be averted and removed, and the patients will be followed up for 90 days.
Northwestern Medicine heart failure treatment and recovery chief Wilcox said: “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.
“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.”
Impella BTR is a forward flow heart pump designed to be implanted through the axillary artery and placed in the left ventricle.
Once placed inside the left ventricle, the device is capable of pumping more than six litres of blood per minute.
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 remodelling using adjunctive therapies for patients with class III / IV heart failure.
It adds to the company’s existing Impella family of heart pumps, including Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, and Impella 5.5 with SmartAssist.
Abiomed chairman, president and chief executive officer Michael Minogue said: “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.
“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.”
