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‘Heart in a box,’ a potential transplant game changer, under FDA review

Posted at 11:04 AM, Apr 16, 2021

A medical device currently under review by the Food and Drug Administration (FDA) could be a game changer when it comes to heart transplants. It's called "heart in a box."

“What the 'heart in a box' allows is for us to take the heart out of the donor, put it in the 'heart in a box' and we animate it, so that as the blood runs into the donor heart, the heart begins to beat again,” said Dr. Pedro Catarino with the Smidt Heart Institute at Cedars-Sinai.

Typically, a heart can be preserved for three hours. The "heart in a box" can double, potentially even quadruple that.

It's in clinical trials now. So far, doctors have done around 500 transplants using the device.

They hope this kind of device can increase the transplant rate by about 20 or 30%.

The device could also let doctors help patients with transplants that are more technically complex and would take more time.

“I think that the quality of the heart transplant improves, so the recovery process improves. The patients may spend less time in intensive care, less time on the ward. They may get a better long-term result,” said Catarino.

Another potential benefit of the device is hearts can travel farther to get transplanted. Catarino recently flew from California to Hawaii to get a heart from a donor.

The heart spent more than seven hours being maintained in a beating state in the "heart in a box" device. The man who received the heart at Cedars-Sinai agreed to do the clinical trial because his age and height could make it very hard to find a donor match. He was told he had six to 12 months left to live if a heart didn't become available. Now, he's doing well.

We don't know how soon the FDA will make a decision on the device. It's already gained approval in Europe and Australia.