First implantation in humans of a novel artificial heart without valves

On July 9, 2024, the first successful human implantation of the BiVACOR Total Artificial Heart was performed as part of an early feasibility study by the U.S. Food and Drug Administration (FDA). The BiVACOR Total Artificial Heart is a single-part, titanium, biventricular rotary pump that employs a magnetically levitated rotor to pump blood and replace both ventricles of a failing heart.

The success of the operation has been proven beyond any doubt weeks after it was carried out, and it has only just been announced publicly.

The surgery was performed by specialists from the THI (Texas Heart Institute). The artificial heart is the work of BiVACOR, a medical device company.

The recipient of this novel artificial heart without valves was a patient with terminal heart failure. The device’s purpose is to keep him alive until a natural heart transplant can be performed.

The objective of this first-in-human clinical study is to evaluate the safety and performance of the BiVACOR Total Artificial Heart as a bridge-to-transplant solution for patients with severe biventricular heart failure or univentricular heart failure for whom left ventricular assist devices are not recommended. Following this first implant, which took place at a Texas Medical Center facility, four additional patients will be enrolled in the study.

“The Texas Heart Institute is excited about the first innovative implant of the BiVACOR Total Artificial Heart. With heart failure remaining a leading cause of death worldwide, the BiVACOR Total Artificial Heart serves as a beacon of hope for the countless patients awaiting a heart transplant,” said Joseph Rogers, M.D., president and CEO of the Texas Heart Institute, who is the principal investigator on this national project. “We are proud to be at the forefront of this medical advancement, collaborating with the dedicated teams at BiVACOR, Baylor College of Medicine and Baylor St. Luke’s Medical Center to transform the future of heart failure care for this vulnerable population.”

Dr. Daniel Timms, founder and CTO of BiVACOR, said, “I am incredibly proud to witness the first human implantation of our total artificial heart. This achievement would not have been possible without the bravery of our first patient and his family, the dedication of our team, and the expert collaborators we have at the Texas Heart Institute. Using advanced MAGLEV technology, our total artificial heart brings us one step closer to providing a much-needed option for people with end-stage heart failure who require support while awaiting a heart transplant. I look forward to the next phase of the clinical trial.”

The BiVACOR Total Artificial Heart. (Photo: BiVACOR, Inc.)

Heart failure is a global epidemic affecting at least 26 million people worldwide and 6.2 million adults in the United States, and its prevalence is increasing. Heart transplants are reserved for those with severe heart failure and are limited to fewer than 6,000 procedures a year worldwide. For this reason, the U.S. National Institutes of Health has estimated that up to 100,000 patients could immediately benefit from mechanical circulatory support devices. The European market is about the same size.

The BiVACOR Total Artificial Heart represents a step change in artificial heart design. It is sized to fit most men and women (with a body surface area of ​​more than 1.4 square meters). Despite its small size, the BiVACOR Total Artificial Heart can provide sufficient cardiac output for an exercising adult male.

Using magnetic levitation technology (the same principle used in high-speed trains) the device has a unique pump design with only one moving part: a double rotor suspended by magnetic forces, with left and right blades located within two separate chambers, forming a double centrifugal impeller that pushes blood from the respective pump chambers into the pulmonary circulation and the systemic (body) circulation.

The total artificial heart has no valves or flexible ventricles; MAGLEV technology enables pulsatile outflow due to the rapid rotation of the pump rotor. The contactless rotor suspension thanks to MAGLEV technology was designed to eliminate the possibility of mechanical wear and provide large blood spaces that minimize blood trauma, thereby providing a durable, reliable and biocompatible replacement heart.

BiVACOR is headquartered in Huntington Beach, California, with clinical offices in Houston, Texas, and international offices in the Gold Coast, Australia. The name BiVACOR is a registered trademark. (Source: Texas Heart Institute)