FDA Grants 510(k) Clearance for Cardiac Transplant Transport System

The FDA granted 510(k) clearance to Paragonix for the Sherpa Pak Cardiac Transport System, which uses cold air and oxygenated perfusion to keep hearts alive during transport before transplants. While the system has the potential to keep hearts alive for up to 12 hours, three times the current standard, the FDA only approved the system for up to four hours initially. This approval marks the first advancement in the way donor hearts are transported in years and has the potential to increase the number of heart transplants performed in the U.S.

Keywords: Cold Temperature, Heart Transplantation, Perfusion, Tissue Donors

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