BiVACOR Gets FDA Early Feasibility Study Tick

Image credit: BiVACOR

A medtech company pioneering a total artificial heart has been granted approval via the United States’ Food and Drug Administration (FDA) to begin an investigational device exemption (IDE) for its first-in-human Early Feasibility Study.

The purpose of study is to evaluate the safety and feasibility of the groundbreaking BiVACOR Total Artificial Heart, a device used in the treatment of people with heart failure awaiting a full heart transplant.

Due to start in 2024, the study will initially enrol three biventricular heart failure patients with hopes of setting the stage for a subsequent pivotal study.

“The FDA approval to begin The BiVACOR Total Artificial Heart EFS is a critical milestone for BiVACOR and is another validation of the remarkable work and accomplishments of the entire BiVACOR team,” said BiVACOR Chief Medical Officer, Dr William Cohn in a press statement.

BiVACOR Chief Technology Officer and former Brisbane local, Dr Daniel Timms added: “We believe this study will build upon the already successful pre-clinical data we have and is expected to set up 2024 as a significant year of milestones for BiVACOR as we continue to build our database of evidence.”

BiVACOR is headquartered in the United States, with an international office in Queensland.

Refer to the press release from BiVACOR for more information.