The Texas Heart Institute in the United States has successfully implanted a BiVACOR total artificial heart (BTAH) into a human body.
The first patient was a 57-year-old man with end-stage heart failure who underwent BTAH implantation at the Texas Heart Institute on July 9 as part of the Early Feasibility Study (EFS) (NCT06174103).
The U.S. Food and Drug Administration (FDA) approved the study in November 2023 under an investigational device exemption.
The study is evaluating BTAH as an option for heart failure patients awaiting a heart transplant, which can take up to three years. A total artificial heart is used to bridge the gap until a heart transplant by replacing the body's blood circulation.
The patient was provided with a donor heart on July 17, eight days after the BTAH was implanted. According to the Texas Heart Institute, the procedure met the EFS goal of evaluating the safety and performance of the BTAH as a solution until heart transplant for patients with severe biventricular heart failure or univentricular heart failure where left ventricular assist device support is not recommended.
BTAH uses a rotary blood pump technology It pumps the same amount of blood during exercise as a healthy man's heart, but is small enough to be transplanted into women and some children.
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The Houston-based company compares magnetic levitation to the technology used in high-speed rail, which uses magnets to lift and move objects without touching other things. In this case, magnetic levitation is being used to keep the rotating part of the pump (called the centrifugal impeller) suspended without touching any surface.
“This device has the potential to be a life-saving bridge until a heart transplant, and further studies may prove its potential as a long-term pump to completely replace a patient's heart,” said Alexis Shafi, chief of cardiac transplant surgery at Baylor St. Luke's Medical Center.
“We hope that the BiVACOR TAH will ultimately save many lives and improve the quality of life for patients who have no other treatment options available.”
Earlier this year, BiVACOR Secured $13 million The company has received funding from the Australian Government's Medical Research Future Fund (MRFF) through the Artificial Heart Frontier Program (AHFP) to advance its overall artificial heart program: $18 million in 2023 and $22 million in 2021. The study plans to enroll four more patients.
According to a report from GlobalData's Medical Information Center, the global cardiovascular disease Device Market It was worth about $60 billion last year and is expected to grow to $86.6 billion by 2030.
GlobalData is Clinical Trials Arena.
