A 58-year-old man in the United States has become the first person in the world to receive a temporary, titanium blood-pumping heart, developed by the medical device company BiVACOR. This pioneering procedure marks a significant milestone in medical science, potentially revolutionizing the treatment of end-stage heart failure.
Unlike traditional hearts, BiVACOR’s TAH does not beat. Instead, it relies on a magnetically levitating rotor to pump blood. This design eliminates the need for flexible chambers or pumping diaphragms, making the device both powerful and compact enough for most men and women. The double-chambered titanium device, roughly the size of a fist, is designed to be durable, resisting corrosion and mechanical wear.
The TAH is powered by an external, portable controller, connected through the abdomen. This setup ensures the device remains operational without the risk of internal friction or wear, thanks to its singular, non-contacting moving part.
The BiVACOR TAH was successfully implanted at Baylor St. Luke’s Medical Center at the Texas Heart Institute. The procedure was complication-free, and the artificial heart sustained the patient for eight days until a donor heart became available. This success is a testament to over a decade of development, multiple design iterations, and extensive animal testing.
Currently, heart transplants are the best option for severe heart failure, but donor hearts are scarce, with fewer than 6,000 transplants occurring worldwide annually. Artificial hearts, therefore, play a crucial role in extending and improving the lives of patients awaiting transplants.
In the past two decades, only one artificial heart, the SynCardia Total Artificial Heart, has received commercial approval from the US Food & Drug Administration (FDA). However, its design has limitations, such as large size and lack of long-term durability.
BiVACOR’s TAH represents a “paradigm shift” in artificial heart technology, designed for longevity and enhanced functionality. While the long-term efficacy in humans is yet to be fully determined, lab tests have shown the device functioning continuously for over four years.
In November 2023, BiVACOR received FDA approval to implant its TAH in up to five patients with end-stage heart failure in 2024. The success of the first implant paves the way for additional transplants, promising a transformative impact on the treatment of heart failure.
The successful development and implantation of BiVACOR’s TAH could significantly reduce the waiting time for heart transplants, offering an off-the-shelf solution that improves the quality of life for patients worldwide. This breakthrough heralds a new era in cardiac care, potentially making mechanical heart replacements a viable long-term option for those suffering from severe heart failure.
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