In a significant development in medical technology, BiVACOR has successfully implanted a fully mechanical heart using maglev technology inside a human patient for the first time. This advancement is a crucial step toward extending the lives of individuals awaiting heart transplants.
The total artificial heart (TAH) was implanted as part of an early feasibility study overseen by the US Food and Drug Administration (FDA). The groundbreaking procedure was carried out at the Texas Heart Institute. According to a statement from the institute, the heart is described as “a titanium-constructed biventricular rotary blood pump with a single moving part that utilizes a magnetically levitated rotor that pumps the blood and replaces both ventricles of a failing heart.”
BiVACOR has been developing this innovative device since 2013. The key advantage of using a magnetically levitated rotor to drive the blood-circulating function is the elimination of friction, which is often a significant cause of wear and tear in mechanical devices. While this TAH is not the first artificial heart— the first successful implant was in 1969—it is the first to incorporate maglev technology, marking a novel approach in the field.
The TAH, roughly the size of a fist, is designed to push blood at a rate of 12 liters per minute. This rate is sufficient to enable an adult male to engage in physical exercise. The device is powered by a small rechargeable external controller, keeping the heart operational. Unlike other artificial hearts that use flexible polymer diaphragms to pump blood—components that are susceptible to wear and tear—BiVACOR’s heart uses a single part suspended in space through magnetism, which potentially offers greater durability and longevity.
Despite its advanced technology, the primary function of this titanium heart is to sustain patients while they await a heart transplant. The goal at this stage of fully mechanical heart development is not permanent replacement but to provide a temporary solution for those with end-stage heart failure.
Daniel Timms, the founder and CTO of BiVACOR, expressed gratitude towards the first patient and their family, as well as the dedicated team and collaborators at the Texas Heart Institute. Timms stated, “Utilizing advanced maglev technology, our TAH brings us one step closer to providing a desperately needed option for people with end-stage heart failure who require support while waiting for a heart transplant. I look forward to continuing the next phase of our clinical trial.”
The next phase involves implanting the titanium hearts into two more patients who will be closely monitored as they wait for their permanent transplant surgery. This ongoing clinical trial is crucial for assessing the efficacy and safety of the device in real-world conditions.
Heart failure is a severe health issue affecting at least 26 million people worldwide. According to the American Heart Association, the demand for heart transplants has doubled over the past 30 years, with over 3,400 people currently on the waiting list. If BiVACOR’s titanium heart passes its clinical trials successfully, it could provide a much-needed interim solution, keeping thousands of patients alive until they receive a donor heart.
Source: The Texas Heart Institute
