The US Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) to BiVACOR’s total artificial heart (BTAH), greenlighting the way for an early feasibility study in ...

The BiVACOR Total Artificial Heart (TAH) is a compact, titanium-constructed device about the size of a fist. Despite its small stature, it packs a powerful punch. It can pump blood at a rate of 12 ...

HOUSTON — In a groundbreaking move, the FDA has approved the second phase of clinical trials for the BiVACOR mechanical heart, a device that could potentially make human heart transplants a thing of ...

HUNTINGTON BEACH, Calif.--(BUSINESS WIRE)--BiVACOR, Inc., a clinical-stage medical technology company developing a total artificial heart (TAH), today announced that Raymond W. Cohen has been ...

Outside of the brain, the heart is probably the organ that you miss the most when it ceases to function correctly. Unfortunately, as we cannot grow custom replacement hearts yet, we have to keep heart ...

As part of a five-patient FDA Early Feasibility Study, BiVACOR TAH successfully bridges all five patients to a donor heart transplant. Data supports the expansion of the Early Feasibility Study to 20 ...

HUNTINGTON BEACH, Calif. & HOUSTON & GOLD COAST, Australia--(BUSINESS WIRE)--BiVACOR, Inc., a clinical-stage medical technology company developing a total artificial heart (TAH), today announced that ...

A 58-year-old man in the United States is the first person in the world to have had his failing heart replaced with a temporary, titanium blood-pumper. The metal organ looks like it was made for the ...

Houston, Texas, July 25, 2024 – 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 ...

To continue reading this content, please enable JavaScript in your browser settings and refresh this page. Preview this article 1 min Bivacor is also gearing up for ...

Milestone Deepens Strategic Partnership with FDA Following Breakthrough Device Designation BiVACOR, Inc., a clinical-stage medical device company developing the world’s first titanium Total Artificial ...