The Texas Heart Institute in the US has successfully implanted BiVACOR’s total artificial heart (BTAH) inside a human being.
The first patient – a 57-year-old man with end-stage heart failure – was implanted with the BTAH at the Texas Heart Institute on 9 July as part of an early feasibility study (EFS) (NCT06174103).
The US Food and Drug Administration (FDA) approved the trial with an investigational device exemption in November 2023.
The study is evaluating BTAH as an option for patients with heart failure who are awaiting a heart transplant, for which patients can wait nearly three years. Total artificial hearts are used to bridge the time to heart transplantation by substituting the pumping of blood around the body.
A donor heart became available for this patient on 17 July, eight days after he was implanted with BTAH. According to the Texas Heart Institute, the procedure met the EFS's goal of evaluating the safety and performance of the BTAH as a bridge-to-heart-transplant solution for patients living with severe biventricular heart failure or univentricular heart failure in which left ventricular assist device support is not recommended.
BTAH uses rotary blood pump technology that pumps as much blood as a healthy male’s heart does during exercise but is small enough to be implanted in women and some children.
The Houston-based company compares the magnetic levitation technology to what is used in high-speed trains. It involves using magnets to lift and move objects without them touching anything else. In this case, it’s used to keep the pump’s spinning part – called a centrifugal impeller – floating without touching any surfaces.
Alexis Shafii, surgical director of heart transplantation at Baylor St Luke’s Medical Center, said: “This device may serve as a life-saving bridge to a heart transplant; future studies may prove its potential as a long-term pump that can effectively serve as a total replacement for a patient’s heart.
“We anticipate the BiVACOR TAH may eventually save numerous lives, as well as improve the quality of life for patients who otherwise have no alternative therapy available.”
Earlier this year, BiVACOR secured $13m from the Australian Government’s Medical Research Future Fund (MRFF) through the Artificial Heart Frontiers Programme (AHFP) to advance its total artificial heart programme. The company raised $18m in 2023, and $22m in 2021. The study will enrol four more patients.
According to a report on GlobalData’s Medical Intelligence Center, the global cardiovascular devices market had a value of nearly $60bn last year and is expected to grow to $86.6bn by 2030.
