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ITL was appointed by OrganOx as a chosen manufacturer for metra®, signing a 5-year manufacturing agreement back in 2019. The first of these devices was released from our UK facility last month.
OrganOx Production Manager, Paul Adams, is regularly on-site at ITL, working alongside Prototype Team Leader Keith Denton and our Production Engineering, Regulatory Affairs, and Quality Assurance departments. Production Engineering has worked closely with OrganOx’s team from the very beginning to ensure a seamless transition into manufacturing at ITL, including performing a comprehensive gap analysis, compiling their Device Master Record (DMR), and complete work-cell set up.
Liver transplantation is a highly successful treatment but is severely limited by the shortage of donor organs. However, many potential donor organs are unable to be used because sub-optimal livers cannot tolerate conventional cold storage – and there is no reliable way to assess organ viability.
The metra is the world’s first fully automated system for keeping a human donor liver functioning for up to 24 hours outside the body. The invention breaks 40 years of traditional organ preservation in ice, doubling the length of time that donor organs can be preserved before transplantation.
To date, OrganOx’s innovative normothermic perfusion technology has supported over 1,000 liver transplants worldwide. It has already received regulatory approval for the European market, and an application has been submitted for approval in the United States.
Craig Marshall, CEO, OrganOx Limited, commented, “As OrganOx continues to grow from strength to strength, a part of the vision of success has been to expand from a single source to a dual source of devices. I am delighted to report the successful execution of this plan, all credit to the respective cross-functional teams at ITL and OrganOx in making this vision a reality.”
Nick Colyer, Managing Director, ITL, said, “It’s been a pleasure to work with a company that’s developed such a transformational product that enables a higher successful transplant rate. ITL has worked with OrganOx for several years, and it gives me great satisfaction to say that the first instrument has been installed in one of Europe’s leading transplant centers. Both teams at ITL and OrganOx have worked well together, and long may it continue.”