Patient Discharged with Total Artificial Heart for the First Time—105 Days Before Transplant

Patient Discharged with Total Artificial Heart for the First Time—105 Days Before Transplant

Source: March 13, 2025 | This article was highlighted by an AHA update.

1. First Patient Discharged with a Total Artificial Heart (TAH)

• A patient in Australia became the first in the world to be discharged while supported by BiVACOR’s total artificial heart (TAH).

• The patient lived with the device for 105 days before successfully receiving a heart transplant on March 6, 2025.

2. Significance of the Procedure

• The implantation was performed at St. Vincent’s Hospital Sydney, marking the first use of BiVACOR’s TAH outside the U.S.

• Traditionally, patients with TAH remain hospitalized while awaiting a donor heart, but this patient’s discharge represents a major milestone in patient mobility and quality of life.

3. Statement from BiVACOR’s Founder

• Daniel Timms, PhD, BiVACOR’s founder and CTO, highlighted that the success of this case demonstrates the safety and reliability of the BiVACOR TAH.

• The patient was able to celebrate his birthday, Christmas, and New Year with his family while free from heart failure symptoms.

4. Overview of BiVACOR’s TAH Technology

• Designed as a bridge to transplant for patients with end-stage heart failure.

• Made of titanium, about the size of an adult’s fist.

• Unlike traditional artificial hearts, it has no valves or flexing ventricle chambers—its only moving part is a magnetically suspended double-sided centrifugal pump impeller.

5. Regulatory Progress

• In December 2024, the U.S. Food and Drug Administration (FDA) reviewed early data from the first five patients implanted with BiVACOR’s TAH.

• The FDA approved expanding the ongoing feasibility study to 15 additional patients.

This groundbreaking case demonstrates significant advancements in total artificial heart technology, improving patient mobility and extending survival while awaiting transplantation.