Paragonix Technologies, Inc. today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the Paragonix SherpaPak™ Pancreas Transport System (PTS)1. Starting immediately, the Paragonix SherpaPak™ PTS will be commercially available to pancreas transplant centers and Organ Procurement Organizations. The Paragonix SherpaPak PTS provides unprecedented thermal and physical protection to the donor pancreas during transport from donor to recipient patients.

“This is an innovation milestone in the preservation and transportation of the human pancreas,” said Matthew Cooper, MD, Director of Kidney and Pancreas Transplantation at the MedStar Georgetown Transplant Institute (MGTI) and Professor of Surgery at Georgetown University School of Medicine. “The donor pancreas is highly susceptible to cold and compression injury during transport. Technologies that improve on the current method of storing a pancreas in an ice cooler are desperately needed. We look forward to evaluation the Paragonix SherpaPak Pancreas Transport System for advanced donor pancreas preservation.”

“We are delighted to provide yet another tool for the transplant community to provide every possible advantage to transplant recipients. The Paragonix SherpaPak PTS is the first pancreas preservation device cleared by the FDA and we are thrilled to have reached this critical market clearance,” said Bill Edelman, Chairman and CEO of Paragonix Technologies. “The most recent U.S. national data available for 2019 suggests that nearly 1,000 transplants took place in the U.S. consisting of either pancreas or simultaneous pancreas plus kidney transplant procedures. We believe the Paragonix SherpaPak™ PTS will be highly impactful for both single-pancreas transplantation as well as for combined pancreas plus kidney transplantation, for which we offer our FDA-cleared Paragonix SherpaPak™ Kidney Transport System (KTS)2 for advanced kidney preservation.”

Source: Company Press Release