Paragonix Technologies announced today that it won FDA 510(k) clearance for its LUNGguard donor lung preservation system.
Paragonix designed the LUNGguard for the hypothermic preservation of lungs during transportation and the eventual transplantation into a recipient using cold storage solutions. LUNGguard is indicated for a storage time of up to eight hours.
Cambridge, Mass.–based Paragonix’s system is designed to ease the stress of donor and transplant centers where the standard of care is packaging lungs in sterile bags on crushed ice without the ability to maintain the conditions of the organ.
LUNGguard is the branded product for part of the Paragonix SherpaLung portfolio, which has previously received support from the Lung Transplant Foundation. The company is also marketing and developing transport devices for hearts, lungs, pancreas, livers and kidneys.
Paragonix said in a news release that it plans to make the LUNGguard commercially available to U.S. lung transplant centers in the second quarter of 2020.
“The recent addition of LUNGguard to our expanding portfolio of organ preservation devices serving all solid organs will provide an important tool for the transplant community,” Paragonix chairman & CEO Bill Edelman said in the news release. “We are thrilled to contribute to improved lung preservation with LUNGguard.”
Dr. Matthew Hartwig, a lung transplant surgeon at the Duke University Lung Transplant Program, added that donor lungs are fragile and require quality management and control over the environmental conditions, and he is looking forward to seeing how the LUNGguard can provide that.
Lung Transplant Foundation CEO Jeff Goldstein
Lung Transplant Foundation CEO Jeff Goldstein said LUNGguard is important because people waiting for a lung transplant need every possible advantage to enable them to receive a lung.
“Based on my own experience as a lung transplant recipient, technologies are critically needed that support and complement the incredible clinical effort afforded by surgical teams and organ procurement organizations as well as the wonderful gift from a donor family,” Goldstein said.