Paragonix Technologies, a medical device company providing devices for organ transplantation, has announced the commercial launch of its PancreasPak organ preservation system.
PancreasPak has already received the US Food and Drug Administration (FDA) 510(k) approval to protect and monitor the donor pancreas during transportation.
The system leverages Paragonix’s proven principles of the SherpaPak Cardiac Transport System, which is used in every three cases across the US.
The company has started booking pre-orders for its PancreasPak technology, with plans to begin a full commercial launch on 1 September 2024.
Paragonix CEO and president Lisa Anderson said: “Our team is thrilled to introduce this advanced technology to the pancreatic transplant community.
“This milestone demonstrates our dedication to advancing the boundaries of organ transplantation excellence. We are honoured to stand at the forefront of preservation and provide unparalleled support to countless patients in need of a heart, lung, liver, and now, pancreas.
“To be at the forefront and be the first company to provide pancreas preservation technology is a tremendous achievement and consistent with our commitment to service all transplant and donor patients.”
Unlike other solid organs, the pancreas is very delicate and vulnerable to damage during transport, and traditional methods would expose the organ to harmful freezing temperatures.
Paragonix said that its PancreasPak system will deliver superior levels of tracking and control in pancreatic transplantation and transform the pancreatic transplant field.
The system establishes a controlled environment, and the preservation digitally monitors the pancreas at an optimal thermal range of 4-8°C for up to 21 hours.
The recommended temperature standard follows the SherpaPak, which was proven to safely extend ischemic times, minimise post-transplant outcomes, and improve 2-year patient survival.
Medical University of South Carolina Department of Surgery vice chair Joseph Scalea said: “This is an incredibly exciting time for pancreas transplantation.
“Preservation impacts organ function, and better preservation would allow us to help more patients. Until now, there has been a distinct lack of innovation within the pancreatic market specifically.
“An advanced preservation device has the potential to change everything. In just a few short months, we will finally have a tool tailored specifically to our needs, that aligns with our goal to substantially enhance organ viability and patient outcomes.”
