BiVACOR, a clinical-stage medical device company, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its innovative Total Artificial Heart (TAH).
The device is designed to support adults with severe biventricular or univentricular heart failure where current treatment options, such as Left Ventricular Assist Devices (LVADs), are not suitable.
The FDA’s Breakthrough Device programme is intended for technologies that could offer significant improvements in the treatment of life-threatening or permanently disabling conditions. The designation enables faster regulatory reviews and enhanced communication with the FDA throughout the development process.
BiVACOR’s artificial heart is the first of its kind to use a magnetically levitated, dual-sided rotor that powers both sides of the heart simultaneously.
The compact design fits most adults and eliminates the need for valves or traditional mechanical parts, which can wear out over time.
The system is engineered to provide natural pulsatile blood flow, reduce trauma to blood cells, and offer long-term durability.
Unlike older artificial heart systems, the BiVACOR TAH aims to offer a simpler, more reliable alternative with fewer complications. Initial clinical data showed no device-related issues or strokes among the first group of patients.
Heart failure affects over six million people in the United States, with many advancing to irreversible biventricular failure. Despite the growing demand, donor heart availability remains limited, with fewer than 4,500 transplants carried out annually.
BiVACOR’s device seeks to address this shortfall by providing a long-term, implantable solution for patients who otherwise have limited options.
