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. Joseph Rogers, CEO of the Texas Heart Institute. “The implantation of a TAH system is a potential treatment option for patients with heart failure who need support while on the heart transplant waiting list and for those who do not qualify for a transplant. The BTAH is designed to replace the function of the native heart completely. It is an impressive technology, and I am excited to see the potential of BTAH in treating patients with severe heart failure.”
More about the BiVacor total artificial heart
The company designed BTAH to replace the function of the native heart completely. The long-term therapy, based on rotary blood pump technology, targets patients with severe biventricular heart failure.
Sized similarly to an adult fist, it uses magnetic levitation technology. Left and right vanes are positioned on a common rotor to form the only moving part, a magnetically suspended double-sided centrifugal impeller. BiVacor designed it to create pulsatile outflow by rapidly cycling the rotational speed of the impeller. The non-contact suspension provides large blood gaps to minimize blood trauma and eliminate mechanical wear.
BiVacor plans to eventually pursue further studies to explore short-term and long-term destination therapy as well.
“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. I am incredibly proud of the unwavering hard work and dedication from our team and network around the globe for achieving this pivotal landmark in the clinical development of our TAH system,” said Daniel Timms, PhD, founder and CTO of BiVACOR.
