PREVIEW

A human has successfully received a titanium heart for the first time in medical history.

The Texas Heart Institute (THI) and BiVACOR, a clinical-stage medical device company, announced on Thursday, July 25, the first-in-human implantation of the BiVACOR Total Artificial Heart (TAH).

The titanium heart uses magnetic levitation, or maglev, technology, similar to that used in high-speed trains. The technology provides a bridge-to-heart-transplant solution for patients with severe conditions until a donor heart becomes available.

On July 9, the Texas Heart Institute implanted the TAH into a critically ill 57-year-old man who was in cardiogenic shock and awaiting a heart transplant. The procedure was part of a U.S. Food and Drug Administration (FDA) Early Feasibility Study (EFS).

The nearly six-hour operation allowed the patient to be liberated from the ventilator on post-operative day three and sit in a chair the same day. On post-op day seven, he was able to walk 150 meters.

On July 17, eight days after the implant, a donor heart became available.

A BiVACOR spokesperson said: "It was transplanted into the patient, removing the BiVACOR TAH and meeting the EFS's goal of evaluating the safety and performance of the BiVACOR TAH as a bridge-to-heart-transplant solution for patients living with severe biventricular heart failure or univentricular heart failure in which left ventricular assist device support is not recommended."

The patient celebrated his 58th birthday whilst continuing to recover from the transplant in hospital.

As the TAH is a titanium-constructed biventricular rotary blood pump that uses magnetic levitation, or maglev, technology, it features a unique pump design with a single moving part.

The non-contact suspension of the rotor via maglev is designed to eliminate the potential for mechanical wear and provide large blood gaps that minimise blood trauma, offering a durable, reliable, and biocompatible heart replacement.

With activity, the device is auto-regulated to provide up to 12 litres of blood flow per minute, which is similar to that pumped by a healthy human heart.

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