FDA Grants Initial IDE Approval for First Human Study of BiVACOR Total Artificial Heart

Thursday, November 30, 2023

BiVACOR, a clinical-stage medical device company focused on advancing a total artificial heart (TAH), has received the green light from the United States Food and Drug Administration (FDA) to initiate an investigational device exemption (IDE) for the inaugural Early Feasibility Study (EFS) of The BiVACOR Total Artificial Heart (BTAH). This study aims to evaluate the safety and feasibility of BTAH as a bridge to heart transplant for individuals grappling with biventricular heart failure. 

The EFS, set to kick off in 2024 with ten potential hospital locations, will initially enroll three patients, including the prestigious Texas Heart Institute in Houston, TX, among others. The study is a precursor to a subsequent pivotal study. The groundbreaking BTAH is designed as a long-term therapeutic solution for severe biventricular heart failure, utilizing innovative rotary blood pump technology. Compact and adaptable, it caters to various patients, including women and some children, while delivering sufficient cardiac output during exercise for adult males. The device incorporates magnetic levitation technology, reminiscent of high-speed trains, featuring a magnetically suspended double-sided centrifugal impeller as its singular moving part. 

This design generates pulsatile outflow without the need for valves or flexing ventricle chambers. The non-contact suspension minimizes blood trauma, eliminates mechanical wear, and presents a durable, reliable, and biocompatible heart replacement. The FDA's approval of The BiVACOR Total Artificial Heart EFS signifies a crucial milestone for BiVACOR, underscoring the commitment and achievements of the entire team. This device introduces a distinctive approach to address clinical challenges for patients with limited options in treating heart failure.

Source: businesswire.com