The US Food and Drug Administration (FDA) has approved the expansion of BiVACOR’s early feasibility study evaluating its titanium total artificial heart (TAH) to additional participants.
The decision follows five positive early implants, all of which US-based BiVACOR said had been completed successfully this year. Procedures were conducted at The Texas Heart Institute, Duke University Hospital, Banner-University Medical Center Phoenix, and Christ Hospital – Heart and Vascular Center.
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BiVACOR’s chief medical officer William Cohn said: “Now that the first five patients have been implanted, we will continue to work with the FDA to provide the necessary data to expand our EFS study.”
BiVACOR’s electromechanical rotary blood pump device aims to support patients with biventricular heart failure while waiting for a heart transplant. Total artificial hearts are used to bridge the time to heart transplantation by substituting the pumping of blood around the body.
Wait times for transplants can be three years, meaning the temporary measure is an important approach to keeping the patient alive in this time frame. US-based Syncardia Systems has developed the only total artificial heart approved by the FDA.
Heart failure affects 26 million people, with heart transplantations prioritised for those with severe heart failure, meaning their number is limited to fewer than 6,000 procedures per year worldwide. Consequently, the US National Institutes of Health estimates that up to 100,000 patients could immediately benefit from mechanical circulatory support (MCS).
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By GlobalDataThe initial phase of BiVACOR’s study supported patients with the BiVACOR TAH System for up to a month while they waited in the hospital for a donor heart to become available. The company reported that five patients were successfully implanted with the TAH, received a heart transplant, and were subsequently discharged from the hospital.
BiVACOR won an investigational device exemption (IDE) from the FDA in November 2023, with the first patient successfully implanted in July 2024.
The device is small enough to be implanted in women and some children but can produce the same cardiac output as an adult male would when exercising. Explaining the technology, BiVACOR draws comparisons to magnetic levitation used in high-speed trains, outlining how a magnetically suspended centrifugal impeller can create pulsatile flow by changing its speed, without the need for valves or flexing chambers. This approach mitigates mechanical wear and provides large blood gaps that minimise blood trauma which improves durability and reliability, BiVACOR claims.
Earlier this year, BiVACOR won $13m via the Australian Government’s Medical Research Future Fund (MRFF)’s Artificial Heart Frontiers Programme (AHFP). This adds to previous separate funding raises of $18m and $22m in 2023 and 2021 respectively.
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 forecast to grow to $86.6bn by 2030.
