Paragonix Technologies out of Cambridge, Massachusetts received clearance in the U.S. for the Sherpa Pak Cardiac Transport System. The Sherpa combines oxygenated perfusion of organs and safe organ storage. The device is indicated for hypothermic transportation of hearts in a cold environment for up to four hours in preparation for a transplant. From the announcement:
Currently, the availability of cardiac transplantation is governed by the “ischemic time”, that being, the elapsed time from heart donation to recipient implantation. According to The International Society Of Heart and Lung Transplantation (“ISHLT”) guidelines(2) for the care of heart transplant recipients, the projected ischemic time should not exceed 4 hours(3,4), limiting the distance available to transport a donor heart. The Paragonix Sherpa(TM) combines innovative oxygenated perfusion of organs and safe organ storage with the goal of extending ischemic time to 12 hours, significantly altering the transportation range of donor hearts. Paragonix Sherpa(TM) is designed to be used in conjunction with any of the currently available organ preservation solutions. Paragonix Sherpa(TM)is fully disposable, eliminating problems associated with maintenance, and contamination. The Sherpa Pak(TM) Cardiac Transport System is intended to be used for the static hypothermic preservation of hearts, up to 4 hours, during transportation and eventual transplantation into a recipient, using cold storage solutions indicated for use with the heart.
Product page: Paragonix Sherpa…
Press release: Paragonix Technologies, Inc., Announces Clearance of a 510(k) Pre-Marketing Notification Application with the US Food and Drug Administration for the Paragonix Sherpa(TM) Cardiac Transport System