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Paragonix Technologies Launches FDA-Cleared BAROguard™ Donor Lung Preservation System Nationwide

Friday, April 05, 2024

Paragonix Technologies, a prominent player in the field of organ transplant technologies and procurement services, has officially launched its latest innovation, the BAROguard™ Donor Lung Preservation System, for commercial use nationwide. Following a successful limited market introduction marked by high demand, this state-of-the-art technology is now available to transplant centers and Organ Procurement Organizations (OPOs) across the United States.

The BAROguard system is a groundbreaking solution that combines established hypothermic preservation methods with active airway management control, ensuring optimal conditions for transporting and safeguarding donor lungs. Equipped with real-time tracking and reporting capabilities, the device offers continuous monitoring of the organ's condition during transit, empowering surgeons and transplant teams with crucial data.

Having obtained FDA 510(k) clearance in August 2023, Paragonix Technologies conducted its first human case at Duke University Medical Center in November 2023. During the limited market release phase, the BAROguard System was successfully utilized by five leading thoracic transplant centers to facilitate safe lung transplantation procedures.

The commercial launch of the BAROguard system signifies a significant advancement in the organ transplantation field, addressing the unique challenges associated with preserving and transporting lungs. Its introduction represents a crucial step forward in improving patient outcomes and addressing the persistent shortage of donor organs.

Furthermore, data collected from the widespread adoption of the BAROguard device will contribute to the GUARDIAN-Lung study, an observational registry aimed at evaluating the clinical outcomes of patients whose donor lungs were preserved using Paragonix lung preservation devices compared to alternative storage methods.

Source: businesswire.com

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