FDA Grants Breakthrough Status to Kidney Preservation Device

Here's something that got me fired up in the best way. In November 2023, the FDA granted breakthrough device designation to an advanced normothermic machine perfusion system designed to preserve donor kidneys for extended periods outside the body. The technology keeps kidneys at body temperature and perfuses them with oxygenated blood, maintaining organ viability far longer than traditional cold storage methods. When I think about the 5,000+ kidneys discarded every year in this country, a technology like this isn't just promising — it's urgent.

The Problem It Solves

Currently, donor kidneys are preserved on ice in cold storage, which provides a preservation window of roughly 24-36 hours — though organ quality deteriorates significantly after 12-18 hours. This time pressure means that logistically complex transplants sometimes fail, and kidneys with extended cold ischemia times are often discarded. In 2022, over 5,000 recovered kidneys in the U.S. were not transplanted. Let that number sit with you: 5,000 kidneys that someone donated, recovered — and then thrown away. Many of these were potentially viable organs lost to time constraints and quality concerns. The system failed them.

"This technology could rescue thousands of kidneys that are currently discarded. Kidneys that sit on ice deteriorate; kidneys that are perfused at body temperature can actually recover and improve." — Device development team

How It Works

The normothermic perfusion device connects to the kidney's blood vessels and pumps warm, oxygenated blood through the organ. Sensors monitor kidney function in real time, measuring urine output, blood flow, and metabolic markers. This allows transplant teams to assess organ quality before transplantation — something impossible with cold storage. Kidneys that appear marginal on ice often improve during warm perfusion, revealing hidden viability.

Breakthrough Designation

The FDA's breakthrough device designation is reserved for technologies that may provide more effective treatment for life-threatening conditions. It accelerates the regulatory review process and provides closer collaboration with the FDA during development. This designation signals the agency's recognition that improved organ preservation is urgently needed.

"Breakthrough designation means the FDA recognizes this could fundamentally change how we preserve and assess kidneys. That's a powerful signal." — Transplant surgeon involved in clinical trials

Impact on the Waitlist

Kidneys account for over 80% of the U.S. transplant waiting list. After a family member needed a kidney transplant, I think about this every single day. If this technology can rescue even a fraction of the 5,000+ kidneys discarded annually, it would represent thousands of additional transplants per year. But here's what I keep saying: we need both better policy and better technology. Preservation tech makes each organ go further. Opt-out donation through Bill A07954 puts more organs into the system. Changing the default saves lives. I couldn't stay on the sidelines while we had two clear levers to pull — policy and technology — and were only pulling one.