IDE approval allows BiVacor to begin its first-in-human early feasibility study (EFS) for the BTAH system. The Houston-based company aims to evaluate BTAH’s safety and feasibility as a bridge to a heart transplant for patients with biventricular heart failure.
BiVacor tapped 10 hospital locations for the study, for which it plans to initially enroll three patients. The company expects to begin the study in 2024 and to use its findings to lead into a subsequent pivotal study. This falls in line with the company’s timeline shared in March when it raised $18 million to support the BTAH’s development.
“I am eager to begin the BiVacor Total Artificial Heart EFS to evaluate what I believe is a promising and potentially life-saving technology,” said Dr. Josep…