The US Food and Drug Administration (FDA) has given the green light for commencement of an investigational device exemption (IDE) first-in-human early feasibility study (EFS) for the Bivacor total artificial heart (BTAH).
The EFS will evaluate the safety and feasibility of BTAH as a bridge to a heart transplant in the treatment of subjects with biventricular heart failure. The EFS has ten hospital location options and will initially enrol three patients, one leading hospital being the Texas Heart Institute in Houston, USA. The study is anticipated to commence in 2024 and will pave 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,” said Joseph Rogers (Texas Heart Institute, Houston, USA). “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 device is designed as the first long-term therapy dedicated for patients with severe biventricular heart failure as an implantable TAH based on rotary blood pump technology. Similar in size to an adult fist, it is designed to be small enough to be implanted in many women and some children yet capable of providing enough cardiac output to an adult male undergoing exercise.
Using magnetic levitation technology, the same principle used in high-speed trains, the design includes left and right vanes positioned on a common rotor to form the only moving part, a magnetically suspended double-sided centrifugal impeller. Even though there are no valves or flexing ventricle chambers, the device is designed to create pulsatile outflow by rapidly cycling the rotational speed of the impeller. The non-contact suspension provides large blood gaps, which is expected to minimise blood trauma and eliminate mechanical wear to offer a durable, reliable, and biocompatible heart replacement.
“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 (Texas Heart Institute, Houston, USA) and Bivacor chief medical officer.
The BTAH is an investigational device limited by federal law for investigational use only. The initial focus of the EFS is planned to be for patients with biventricular heart failure who need a mechanical circulatory support device for a bridge to a transplant. It is envisioned that after the EFS, further studies will explore short-term and long-term destination therapy.