The Texas Heart Institute (THI) and BiVACOR, a clinical-stage medical device company, announced the successful first-in-human implantation of the BiVACOR Total Artificial Heart (TAH) on July 9, 2024. This procedure is part of the U.S. Food and Drug Administration (FDA) Early Feasibility Study (EFS). The BiVACOR TAH, a titanium biventricular rotary blood pump with a single moving part, uses a magnetically levitated rotor to pump blood and replace both ventricles of a failing heart.

Figure 1. Texas Hospital Successfully Implanted a Valveless Artificial Heart, A 'Groundbreaking' Milestone.

Figure 1 shows Texas hospital successfully implanted a valveless artificial heart, a 'groundbreaking' milestone. the goal of this initial clinical study is to assess the safety and effectiveness of the BiVACOR TAH as a bridge-to-transplant option for patients with severe biventricular or univentricular heart failure, where left ventricular assist devices are not suitable. Following the successful implantation at Baylor St. Luke's Medical Centre in the Texas Medical Centre, the study plans to enroll four additional patients.

Daniel Timms, PhD, Founder and Chief Technology Officer of BiVACOR, expressed his pride in the successful first-in-human implantation of their Total Artificial Heart (TAH). He acknowledged the bravery of their first patient and their family, the dedication of their team, and the expertise of their collaborators at The Texas Heart Institute. "Using advanced MAGLEV technology, our TAH brings us closer to offering a much-needed option for individuals with end-stage heart failure who are awaiting a heart transplant. I am excited to move forward with the next phase of our clinical trial," Timms said.

Heart failure is a global crisis, affecting at least 26 million people worldwide, including 6.2 million adults in the U.S., and its prevalence is rising. With fewer than 6,000 heart transplants performed annually worldwide, the U.S. National Institutes of Health estimates that up to 100,000 patients could benefit from mechanical circulatory support (MCS), with a similar need in the European market.

The successful implantation of BiVACOR’s TAH underscores the promise of innovative technologies in addressing critical issues in cardiac care, such as long transplantation waitlists. Both BiVACOR and The Texas Heart Institute are dedicated to advancing cardiac medicine and enhancing patient outcomes globally.

References:

1. https://www.news-medical.net/news/20240725/Texas-Heart-Institute-and-BiVACOR-achieve-milestone-with-total-artificial-heart-implantation.aspx
2. https://newatlas.com/medical/maglev-titanium-heart-bivacor/

Cite this article:

Gokila G (2024), Texas Hospital Successfully Implanted a Valveless Artificial Heart, A 'Groundbreaking' Milestone, Anatechmaz, pp. 260