FDA Approves 50cc Total Artificial Heart System as Bridge to Transplantation

The Food and Drug Administration (FDA) approved the 50cc temporary Total Artificial Heart System (50cc TAH-t) developed and manufactured by SynCardia Systems, LLC as a bridge to heart transplant for patients who are at imminent risk for death from biventricular failure.¹

A similar device, 70cc TAH-t, received FDA approval in 2014. The 70cc and 50cc TAH-t are the only 2 devices that have been approved by the agency for dischargeable biventricular support. Thanks to a 37.5% reduction in size compared with 70cc TAH-t, the 50cc version can fit individuals with smaller frames (52% women; 22%  <18 years; ages, 10-72 years; smallest body surface area, 1.16 m²).² The 50cc TAH-t has a peak cardiac output of 7.5 L/min vs 9.5 L/min for the 70cc device.²

Patients implanted with a TAH-t device retain high priority for a donor organ (ie, United Network for Organ Sharing [UNOS] Status 2), and do not need to remain hospitalized. The TAH-t devices are indicated for patients with heart failure who no longer benefit from sole medical treatment, and allow to restore hemodynamics, stabilize patients, and achieve end-organ recovery.

“By its very nature the process of allocating a limited number of precious donor hearts to a growing population of patients needing transplantation can lead to some people having to wait longer than we might like,” said Kim Rallis, transplant executive director at the University of Louisville Health–Jewish Hospital in Kentucky and a board member of the Organ Procurement and Transplantation Network (OPTN)/UNOS. “The total artificial heart plays an important role in giving hope to some patients waiting for a heart transplant by not only allowing them to survive to transplant but to thrive after transplant by allowing for end-organ recovery.”

Clinical studies conducted within SynCardia Systems have shown that 77.1% of patients implanted with a TAH-t device survive after heart transplantation or after ≥180 days on support.³

“The approval of the 50cc TAH-t is a significant step forward to providing this unique technology for many children and women who in the past did not have the opportunity because of their size. The TAH-t provides hope for those patients who are not well supported by our traditional forms of mechanical circulatory assistance,” noted David Morales, MD, director of congenital heart surgery at Cincinnati Children’s Hospital in Ohio.¹

For more information on the 50cc TAH-t device, visit SynCardia Systems.

References

1. Press Release. SynCardia Systems, LLC. 50cc temporary Total Artificial Heart (TAH-t) now FDA-approved. https://www.globenewswire.com/news-release/2020/03/09/1997447/0/en/SynCardia-Systems-LLC-50cc-temporary-Total-Artificial-Heart-TAH-t-Now-FDA-Approved.html. Accessed March 23, 2020.
2. Syncardia. 50cc total artificial heart. https://syncardia.com/clinicians/our-products/50cc-total-artificial-heart/. Accessed, March 23, 2020.
3. Data on file at SynCardia Systems, LLC. Tucson, AZ. Patients implant from 10/18/18 to 8/31/19 (n=35). Positive result defined as survival to heart transplant or >180 days on support.