The Texas Heart Institute has achieved a groundbreaking milestone with the first successful implantation of the BiVACOR Total Artificial Heart. This revolutionary device aims to provide a new lifeline for patients with severe heart failure, representing a significant advancement in cardiac care.
The Texas Heart Institute, in collaboration with BiVACOR®, has made a historic stride in cardiac care with the successful first-in-human implantation of the BiVACOR Total Artificial Heart (TAH). This pioneering procedure was performed on July 9, 2024, at Baylor St. Luke’s Medical Center as part of the FDA-approved Early Feasibility Study.
The BiVACOR TAH, constructed from titanium, features a unique biventricular rotary blood pump with a single moving part. The device employs a magnetically levitated rotor to pump blood, effectively taking over the function of both ventricles in a failing heart.
Revolutionizing Heart Failure Treatment
This new technology aims to address the critical needs of patients with severe biventricular heart failure or those who cannot be supported by a left ventricular assist device. Designed as a bridge-to-transplant solution, the first-of-its-kind study will enroll four more patients following the successful initial implantation.
Joseph Rogers, president and CEO of the Texas Heart Institute, expressed immense enthusiasm about this breakthrough, highlighting its potential to save lives.
“The Texas Heart Institute is enthused about the groundbreaking first implantation of BiVACOR’s TAH. With heart failure remaining a leading cause of mortality globally, the BiVACOR TAH offers a beacon of hope for countless patients awaiting a heart transplant,” he said in a news release. “We are proud to be at the forefront of this medical breakthrough, working alongside the dedicated teams at BiVACOR, Baylor College of Medicine and Baylor St. Luke’s Medical Center to transform the future of heart failure therapy for this vulnerable population.”
Addressing a Global Epidemic
Heart failure continues to be a pressing global health issue, affecting at least 26 million people worldwide, including 6.2 million adults in the United States. The shortage of available donor hearts for transplantation — limited to fewer than 6,000 procedures annually — underscores the urgent need for alternatives like the BiVACOR TAH. The U.S. National Institutes of Health has projected that up to 100,000 patients across the country could benefit from mechanical circulatory support, with a similarly high demand in Europe.
The successful implantation of BiVACOR’s TAH is a testament to the potential of innovative medical technologies to tackle the challenges of heart transplantation waitlists and heart failure.
Both BiVACOR and The Texas Heart Institute are committed to advancing cardiac medicine, with the promise of improving patient outcomes globally.
The Future of Artificial Heart Design
The BiVACOR TAH represents a paradigm shift in artificial heart design. Despite its compact size, suitable for most men and women (Body Surface Area >1.4 m²), the TAH can provide sufficient cardiac output for an adult male during exercise. Its incorporation of magnetic levitation, similar to the technology in high-speed trains, offers a durable and biocompatible heart replacement.
This breakthrough marks a significant advancement in the mission to combat heart failure, offering new hope to patients worldwide.