BiVACOR Gets IDE OK for Feasibility Study of Total Artificial Heart

BiVACOR, a clinical-stage company developing a total artificial heart (TAH), has been granted investigational device exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin a fist-in-human early feasibility study (EFS) of .
 
The EFS will assess the BiVACOR total artificial heart (BTAH)’s safety and feasibility as a bridge to a heart transplant when treating patients with biventricular heart failure. The EFS has ten hospital location options and will initially enroll three patients.
 
The company expects the study to begin in 2024, paving the way for a subsequent pivotal study.
 
“I am eager to begin the BiVACOR Total Artificial Heart EFS to evaluate what I believe is a promising and potentially life-saving technology,” Joseph Rogers, MD, National P.I. and CEO of the Texas Heart Institute, told the press. “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.”
 
The BTAH is designed as the first long-term therapy for patients with severe, biventricular heart failure as an implantable TAH based on rotary pump technology. It’s about the size of an adult fist, small enough to be implanted in many women and some children—yet capable of generating enough cardiac output to an adult male exercising.
 
Using magnetic levitation tech, it includes left and right vanes positioned on a common rotor to form the only moving part, a magnetically suspended, double-sided centrifugal impeller. Pulsatile outflow is created by rapidly cycling the impeller’s rotational speed.
 
Non-contact suspension also offers large blood gaps to minimize blood trauma and remove mechanical wear.
 
“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. This Device will provide a unique approach to help patients currently with limited clinical options,” said William Cohn, MD, Heart Surgeon at the Texas Heart Institute and BiVACOR’s chief medical officer.
 
“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,” added Daniel Timms, Ph.D., founder and CTO of BiVACOR