History
2024: Implantation of a fully mechanical heart
In early July 2024, the Texas Heart Disease Institute in the United States successfully implanted a fully mechanical heart manufactured by BiVACOR in humans.
The first patient, a 57-year-old man with end-stage heart failure, underwent surgery directly at the operating institute on 9 Jul 2024 as part of a preliminary feasibility study of such surgery (NCT06174103). Regulators approved this study back in November 2023, but researchers were expecting a suitable patient.
A fully mechanical heart uses rotary pump technology that pumps the same amount of blood as a healthy man's heart during exercise, yet is small enough to be implanted in women and even some children and teenagers.
Researchers see a mechanical artificial heart as an option to support heart failure patients waiting for a heart transplant. Given that many patients are forced to wait nearly three years for suitable transplants, a fully artificial heart can shorten waiting times and save lives for people in particularly severe conditions, such as severe biventricular heart failure or single ventricular heart failure, in which the use of a conventional left ventricular support device is discouraged.
A patient who underwent experimental surgery was able to receive a donor heart as early as July 17, just eight days after implanting an artificial heart. According to the Texas Heart Research Institute, the procedure was able to achieve the set goals of assessing the safety and effectiveness of the mechanical heart used as transient therapy before transplantation.[1]
2023: $18 million investment
On March 29, 2023, BiVacor, an artificial heart developer, announced an investment of $18 million. The money will be used to fund ongoing research and development, as well as to organize comprehensive tests of products. In addition, personnel changes are planned - new specialists will be accepted for key leadership positions.
BiVacor artificial heart is designed for people with severe biventricular heart failure. The solution is based on the technology of a rotary blood pump. The design includes left and right blades located on a common rotor and forming a single moving part: a double-sided impeller on a magnetic suspension. This design minimizes mechanical wear, making the artificial heart more durable, reliable and biocompatible. In addition, contactless magnetic suspension provides effective blood flow.
BiVacor's new funding round has been spearheaded by Cormorant Asset Management and OneVentures: The allocation is through the OneVentures Healthcare Fund III. The money will help develop a fully artificial next-generation heart that could serve as a transition solution for those awaiting a heart transplant, or even become a long-term alternative to a heart transplant.
 | We are extremely grateful for the continued support from our core investors. With this funding, we will be able to double the size of our team, as well as attract new specialists to research and development. We are well positioned to expand preclinical activities and are aiming to conduct the first human trial in 2024, "said BiVacor CEO (and former Abiomed executive) Dr Thomas Vassiliades[2] |  |
Notes
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