Paragonix Earns FDA Clearance for Donor Lung Transporter
The FDA granted Paragonix 510(k) clearance for its LUNGguard donor lung preservation system, which preserves donor lungs during transportation to the recipient.
The device uses cold storage technology indicated for use with the lungs, with an intended organ storage time of up to eight hours.
Generally, donor lungs are transported in sterile bags on crushed ice. The LUNGguard system offers static hypothermic conditions and reporting of preservation and transport data.
The company plans to make the system available to U.S. lung transplant centers in the second quarter.