Paragonix Technologies, a US-based medical device company, has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Sherpa Pak kidney transport system.
The Paragonix Sherpa Pak kidney transport system is a device intended to provide a safe, consistent method for cold ischemic storage and transport of donor organs to recipients for transplantation.
The new kidney transport system is intended to be used for the static hypothermic preservation of kidney organs during transportation and eventual transplantation into a recipient, using cold storage solutions indicated for use with this organ.
It can maintain donor organ storage temperature between 4°C and 8°C through 24 hours.
Paragonix Technologies COO and co-founder Lisa Anderson said that this 510(k) clearance will expand the company’s 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 Kidney Transport System will be cleared for commercial distribution," Anderson added.
"This is the third in a series of regulatory clearances while we continue our development of several additional Sherpa products."
In February 2014, Paragonix received approval of a second 510(k) premarket notification by the FDA for the Paragonix Sherpa cardiac transport system.