FDA Approval of Heart-in-a-Box Technology Advances Hope for Patients Awaiting a Heart Transplant

May 11, 2022

The Minneapolis Heart Institute Foundation team is celebrating a big accomplishment that was made possible thanks to the bravery of patients, the determination of doctors, the support of our community, and groundbreaking technology. A new heart transplant device, known as the heart-in-a-box, was recently approved by the FDA (OCS Heart manufactured by Transmedics).

MHIF has been a leader in heart transplant research and was one of only seven sites in the U.S. participating in this pivotal study that was required to gather the data necessary for FDA approval of the heart-in-a-box technology. This milestone is important to patients as it provides hope for the 3,400+ patients awaiting heart transplants in the U.S. (source, UNOS).

The Minneapolis ABC affiliate, KSTP, recently aired a second story about the heart-in-a-box research, a patient who participated in the study at MHIF and the good news that the manufacturer received FDA approval for the technology. The story was a follow-up to an original feature that aired in February 2021 and featured a recent interview with Dr. Benjamin Sun, as well as perspectives from Dr. Karol Mudy and Dr. Bassam Shukrallah, who were both interviewed for the original story. You can view the story on the KSTP website.

We are grateful to the patient, Kevin Manion, for his willingness to participate in research and share his story. As Dr. Sun shared in the interview with KSTP when he talked about patients:

“They’re the brave ones. They really are because they are willing to put their lives out there to help us move the field forward,” said Dr. Sun. “They have to have the intestinal fortitude as well as the altruism to participate and put their lives on the line to help us learn.”

Our team at MHIF is optimistic for what this means for more patients getting the heart transplants they need as the world of care and technology continues to advance for the benefit of all patients.

Read more about Kevin Manion’s experience as a heart research patient here.

MHIF is celebrating our 40th Anniversary in 2022!

Interested in lifesaving and life-enriching research and education? Stop by frequently to read 40 inspiring stories and stay tuned for special events: