Bivacor Keeps Total Artificial Heart Market Pumping with IDE

Bivacor has been awarded an IDE for an early feasibility study of its total artificial heart. The Huston, TX-based company said the study is set to begin in 2024 and would set the stage for a subsequent pivotal study.

The Bivacor Total Artificial Heart is designed as the first long-term therapy dedicated for patients with severe biventricular heart failure as an implantable based on rotary blood pump technology.

Similar in size to an adult fist, the device 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 minimize blood trauma and eliminate mechanical wear to offer a durable, reliable, and biocompatible heart replacement.

“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,” said Daniel Timms, PhD, Founder and CTO of Bivacor.

Earlier this year, the company raised $18 million led by Cormorant Asset Management and OneVentures, through the OneVentures Healthcare Fund III to support the early feasibility study.

Bivacor isn’t the only company to recently have rumblings in the total artificial heart market. In June, Ecouen, France-based Vygon announced a plan to develop a vascular graft for the outflow tract of Carmat's Aeson artificial heart. Vygon said it would adapt its existing polythese vascular graft to make it compatible with Carmat's device.