Paragonix Technologies, Inc. today announced that it has successfully completed filing of a Pre-Marketing Notification Application (510(k)) with the US Food and Drug Administration (FDA) for its Sherpa Pak™ Transporter 1,2. The Sherpa Pak™ Transporter is indicated for the static hypothermic preservation of kidneys during transportation and eventual transplantation into a recipient, using cold storage solutions indicated for use with the kidney.
Lisa Anderson, PhD, Chief Operating Officer and Co-Founder for Paragonix commented, “We are excited to have filed a Pre-Marketing Notification Application (510(k)) with FDA for the Sherpa Pak™ Transporter. This 510(k) pre-market application, when cleared by FDA, will expand our product portfolio of organ preservation technologies. Following excellent market reaction to our Sherpa Pak™ Cardiac Transport System, we anticipate significant clinical interest for this innovative technology in the markets where the Sherpa Pak™ Transporter will be cleared for commercial distribution. This is the third in a series of regulatory applications while we continue our development of several additional Sherpa products.” A. Benedict Cosimi, MD 3 (Chief Emeritus, Department of Transplantation, Massachusetts General Hospital, Boston; Professor of Surgery at Harvard Medical School) commented, “I have devoted many decades to the science and clinical aspects of kidney transplantation. There has been, and continues to be, a persistent shortage of organs suitable for transplantation. Improvements in kidney preservation methods would greatly benefit the field. I am excited, therefore, to see advances such as these reach the pre-market submission stage.”
1 On February 6, 2013, FDA cleared for commercial distribution the Sherpa Pak™ Cardiac Transport System 510(k) pre-market submission.
2 Patents pending.
3 Dr. Cosimi is a member of the Paragonix Scientific Advisory Board.