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Breakthrough in Medical Heart Devices
  • September 2, 2024
  • KBA Attorneys
  • No Comments

Breakthrough in Medical Heart Devices

In a remarkable breakthrough in medical heart devices, BiVACOR has successfully implanted the first fully mechanical heart into a human patient. This pioneering achievement represents a significant leap forward in cardiac care, providing new hope for individuals awaiting heart transplants.

The mechanical heart is called a Total Artificial Heart (TAH). It is a titanium-constructed similar to the size of an actual heart. 

How Does BiVACOR’s TAH Work? 

Unlike other TAH technologies that exist, The BiVACOR TAH uses an electro-mechanical rotary blood pump, with a bearingless motor that pumps the blood throughout the body. This new construction allows for less friction, putting less stress on the heart. 

Other artificial hearts on the market use flexible polymer diaphragms to pump blood. This puts strain on the heart, and does not last very long. 

Benefits of the BiVACOR TAH

  • Replaces both ventricles of a failing heart.
  • Can pump blood at a rate of 12 liters per minute
  • Can support an adult male during exercise
  • Frictionless environment
  • Longer-lasting than current models
  • More reliable than current models

Who Needs it? 

Patients waiting for heart transplants will benefit from this new innovation. The line for patients waiting for new hearts is long, and some patients wait years to receive a new heart. BiVACOR’s new TAH will help patients waiting in this long line to limit the wear and tear on their hearts before they receive a transplant. 

The First Implantation

On July 9, 2024, the FDA approved BiVACOR’s TAH and the Texas Heart Institute implanted the first one into a patient. The next step for this study is to implant the mechanical heart into four more patients. Slowly introducing this innovative technology to more patients, will allow for safety and performance evaluations. If the clinical trials with the current patients receiving the heart see success, this could help hundreds of thousands of future patients. 

 

KBA’s Involvement With Medical Heart Device’s

While KBA is not endorsing this product and has not evaluated it for safety, it may bring hope for the future in the heart medical device area. We care because we’ve seen several failures recently. 

Companies issued many recalls of heart devices. We have observed several FDA recalls due to patient injuries. KBA helps people who suffer injuries from failed heart related medical devices. Impella and HeartMate are two examples of heart devices that have failed patients.

Contact Us if you are an  injured patients from any failed medical device, and we can discuss your options.

KBA is monitoring BiVACOR’s TAH in the upcoming months. We will check back with any reported injuries regarding the device.