The Texas Heart Institute (THI) and BiVACOR®, a clinical-stage medical device company, announced today the successful first-in-human implantation of the BiVACOR Total Artificial Heart (TAH) as part of the U.S. Food and Drug Administration (FDA) Early Feasibility Study (EFS) on July 9, 2024. BiVACOR's TAH is 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.
The 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. 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.
The pumping motion of the BiVACOR’s Total Artificial Heart (TAH) is governed by a maglev driven rotor, which spins to circulate blood around the body while suspended contactlessly inside the titanium housing of the compact implant. Once installed, the valveless heart is theoretically capable of supporting an exercising adult male, and can be manipulated to pump faster or slower using a smart external controller. It is also hoped that its frictionless design will remove the risk of mechanical wear, and ultimately, failure.
On July 9, surgeons at the Texas Medical Center successfully implanted the first human patient with the maglev-powered heart, as part of an FDA approved trial to test the safety and feasibility of the artificial organ. As it stands, BiVACOR’s heart is not being developed as a permanent replacement, but rather as a bridging implant to keep patients alive while they wait for a donor heart to become available.
Thankfully, the BiVACOR TAH was able to keep the patient alive for a full eight days, after which surgeons were able to remove the artificial organ in order to replace it with a donor heart on July 17. The patient is now recovering well, according to a recent update from the Texas Heart Institute.
The 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. 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.
The pumping motion of the BiVACOR’s Total Artificial Heart (TAH) is governed by a maglev driven rotor, which spins to circulate blood around the body while suspended contactlessly inside the titanium housing of the compact implant. Once installed, the valveless heart is theoretically capable of supporting an exercising adult male, and can be manipulated to pump faster or slower using a smart external controller. It is also hoped that its frictionless design will remove the risk of mechanical wear, and ultimately, failure.
On July 9, surgeons at the Texas Medical Center successfully implanted the first human patient with the maglev-powered heart, as part of an FDA approved trial to test the safety and feasibility of the artificial organ. As it stands, BiVACOR’s heart is not being developed as a permanent replacement, but rather as a bridging implant to keep patients alive while they wait for a donor heart to become available.
Thankfully, the BiVACOR TAH was able to keep the patient alive for a full eight days, after which surgeons were able to remove the artificial organ in order to replace it with a donor heart on July 17. The patient is now recovering well, according to a recent update from the Texas Heart Institute.
