Paragonix Technologies has announced that it has successfully completed filing of a 510(k) Pre-market notification with the US Food and Drug Administration (FDA) for its Sherpa Perfusion cardiac transport system. This represents the fourth pre-market application for the company’s Sherpa family of organ preservation and transport technologies. The Sherpa Perfusion cardiac transport system is intended to be used for either hypothermic static preservation or oxygenated perfusion preservation of hearts during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the heart. The intended organ storage time for the Sherpa Perfusion cardiac transport system is up to four hours.
This announcement follows the recent clearances of several Pre-Marketing Notifications (510(k)) with the US Food and Drug Administration (FDA) for the Paragonix Sherpa Pak transporter systems. The Sherpa Pak transport systems are indicated for the static hypothermic preservation of organs during transportation and eventual transplantation into a recipient.
William Edelman, chairman and chief executive officer, for Paragonix comments, “Following our recent Sherpa pre-market clearances granted by FDA for both heart and kidney storage and transport, and the positive responses we have received from the clinical community for the Sherpa portfolio of organ transport products, we are pleased to have filed a 510(k) Pre-market Notification with the FDA for the Sherpa Perfusion cardiac transport system.”
Len Golding, chief medical officer for Paragonix Technologies, and retired consultant staff in the Department of Biomedical Engineering at the Cleveland Clinic, comments, “I believe that the clinical advantages of the Sherpa Perfusion cardiac transport system include its ease-of-use, systematisation of organ recovery and preservation process, and the lack of expensive capital equipment necessary to perform its function. I have devoted an important part of my career to finding solutions for organ preservation and transport as they are in short supply world-wide.”