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). This was part of the U.S. (FDA) Early Feasibility Study (EFS) on July 9, 2024.

德克萨斯心脏研究所（THI）和临床阶段医疗器械公司BiVACOR宣布首次成功植入BiVACOR全人工心脏（TAH）。这是2024年7月9日美国（FDA）早期可行性研究（EFS）的一部分。

Following this first implantation completed at Baylor St. Luke’s Medical Center in the Texas Medical Center, four additional patients are to be enrolled in the study.

在德克萨斯医学中心贝勒圣卢克医学中心完成第一次植入后，另外四名患者将被纳入研究。

This first-in-human clinical study aims to evaluate the safety and performance of the BiVACOR TAH as a bridge-to-transplant solution for patients with severe biventricular heart failure or univentricular heart failure in which left ventricular assist device support is not recommended.

这项首次人体临床研究旨在评估BiVACOR TAH作为严重双心室心力衰竭或单心室心力衰竭患者移植解决方案的桥梁的安全性和性能，其中不建议使用左心室辅助装置支持。

BiVACOR’s TAH is a titanium-constructed biventricular rotary blood pump with a single moving part that uses a magnetically levitated rotor that pumps the blood and replaces both ventricles of a failing heart.

BiVACOR的TAH是一种钛合金结构的双心室旋转式血泵，具有单个运动部件，使用磁悬浮转子泵送血液并替代衰竭心脏的两个心室。

Daniel Timms, PhD, Founder and Chief Technology Officer of BiVACOR said, “I’m incredibly proud to witness the successful first-in-human implant of our TAH. This achievement would not have been possible without the courage of our first patient and their family, the dedication of our team, and our expert collaborators at The Texas Heart Institute.

BiVACOR创始人兼首席技术官Daniel Timms博士说：“我非常骄傲地看到我们的TAH首次成功植入人体。如果没有我们的第一位患者及其家人的勇气，我们团队的奉献精神以及德克萨斯心脏研究所的专家合作者，这一成就是不可能实现的。

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.”.

利用先进的磁悬浮技术，我们的TAH使我们更接近为等待心脏移植时需要支持的终末期心力衰竭患者提供急需的选择。我期待着继续我们临床试验的下一阶段。”。

This successful implantation of BiVACOR’s TAH highlights the potential of innovative technologies to address critical challenges in cardiac care, such as long transplantation waitlists.

BiVACOR的TAH的成功植入突出了创新技术解决心脏护理关键挑战的潜力，例如长时间的移植候补名单。

“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,” said Dr. Joseph Rogers, President and Chief Executive Officer of The Texas Heart Institute and National Principal Investigator on the research.

德克萨斯心脏研究所（Texas Heart Institute）总裁兼首席执行官兼该研究的国家首席研究员约瑟夫·罗杰斯（Joseph Rogers）博士表示：“德克萨斯心脏研究所（Texas Heart Institute）对首次植入比瓦科（BiVACOR）TAH的开创性研究非常感兴趣。心力衰竭仍然是全球死亡的主要原因，比瓦科（BiVACOR）TAH为无数等待心脏移植的患者提供了希望的灯塔。”。

“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.”.

“我们很自豪能够站在这一医学突破的前沿，与比瓦科、贝勒医学院和贝勒圣卢克医学中心的专业团队合作，为这一弱势群体改变心力衰竭治疗的未来。”。